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Pharmazie: 40 Jobs in Neubiberg

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Pharmazie

Clinical Development Scientist (f/m/d)

Do. 02.12.2021
Garching bei München
ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).Reporting to the Head of Clinical Development, in his / her position the Clinical Development Scientist (f/m/d) will help the Medical Leads in managing the scientific and medical activities of the different projects in close collaboration with external sub-contractors (CROs), internal and external experts as well as all ITM departments (Regulatory Affairs, Clinical Operations, R&D and Medical Affairs etc.). Support the project Medical Lead(s) Contribute from study strategy and design, protocol concept to data analysis, interpretation and final study report to deliver the clinical development activities which ensure consistency with the clinical development strategy Appropriately interact with Key Opinion Leaders (KOLs), collaborators, CROs, advisory boards, DSMB etc. Contribute to the medical monitoring and data cleaning of ongoing studies Ensure that high quality documents (protocols, IBs, ICFs etc.) are developed aligned to the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Participate in eCRF development Participates in data review ongoing through study including interim analyses, in-stream data review etc. Present the scientific rationale and study design at Investigator Meetings and respond to scientific questions arising from sites during study conduct Ensure prompt, quality communications with sites regarding protocol clarification and procedural queries Implement new business processes and strategies and also proactively identify issues and propose strategies to manage implications and risks on clinical study / Clinical Development plan Contribute to documents for regulatory submissions and advisory requirement, including scientific advice, IND / CTA, and NDA / BLA / MAA Contribute to all regulatory reporting requirements (e.g., DSUR, INDSRs etc.) Ensure prompt, quality responses to Regulatory Agencies, Institutional Review Boards (IRB) / Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC) etc. Deliver of end-of-study reports and publication/presentation of results Advanced life science degree (PhD, preferably MD) Ability to work in a hierarchically flat, matrix environment Ideally a minimum of one to two years of professional experience as clinical scientist in a drug / biologic developing company, ideally in oncology indication Strong working knowledge of the clinical drug development process, clinical trial design, medical monitoring, data management (including CDISC standards) and biostatistics Ability to understand, integrate, analyse and interpret clinical data Fluency in English Good management, interpersonal, communication, negotiation and problem-solving skills A modern workplace and exciting opportunities in an evolving and fast growing company Challenging and varied projects in interdisciplinary, multicultural and highly professional teams A collegial corporate culture and short communication channels Flexible working hours with an attractive salary package and diverse corporate benefits
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Head of Quality Management (m/w/d)

Do. 02.12.2021
Ottobrunn
Minaris Regenerative Medicine GmbH ist ein globaler Partner für Auftragsforschung und Lohnherstellung. Wir produzieren hochmoderne Zell- und Gentherapien nach den Vorgaben der Guten Herstellungspraxis (GMP) für die Anwendung im Menschen. Bei uns tragen Sie aktiv zum medizinischen Fortschritt bei und geben schwer kranken Patienten Hoffnung. Weitere Informationen finden Sie auf unserer Webseite rm.minaris.com. Unter „Bewerben“ können Sie mit nur wenigen Klicks Ihren Lebenslauf hochladen. Wir freuen uns auf Sie! Zur Verstärkung unseres Management Teams am Standort Ottobrunn suchen wir eine/n: Head of Quality Management (m/w/d) Strategische wie operative Weiterentwicklung des GMP konformen Qualitätsmanagementsystems für die Herstellung von Zell- und Gentherapeutika (ATMP’s) Prozessverantwortung für sämtliche Prozesse des QM-Systems Sicherstellung und Optimierung der Schnittstellen des Qualitätsmanagements zu benachbarten Abteilungen Planung, Vorbereitung und Durchführung von (internationalen) Kundenaudits und Behördeninspektionen Durchführung von Audits für die Qualifizierung von Lieferanten und Prüflaboren Führen, Fördern und Weiterentwickeln der Mitarbeiter im Verantwortungsbereich Verantwortliche Erstellung des jährlichen Budgets einschließlich Personalplanung und Investitionen für den eigenen Bereich Abgeschlossenes pharmazeutisches oder naturwissenschaftliches Studium oder vergleichbare Qualifikation Mehrjährige Berufserfahrung in der Ausübung der Tätigkeit als Leiter der Qualitätssicherung oder -kontrolle im Bereich der Arzneimittelherstellung oder -prüfung oder vergleichbare Qualifikation Erfahrung im Bereich der Arzneimittel für neuartige Therapien (Advanced Therapy Medicinal Products, ATMPs) wünschenswert Hohe fachliche Kompetenz und tiefe Kenntnis der gesetzlichen Vorschriften im Bereich Arzneimittelherstellung, -prüfung und -freigabe Mehrjährige Erfahrung in der Analytik gemäß § 15 AMG im Hinblick auf eine mögliche Erlangung der Sachkenntnis zur Sachkundigen Person gemäß § 14 AMG von Vorteil Führungsexpertise und damit verbunden die Fähigkeit, Ihr Team zu fördern und zu motivieren um Höchstleistungen im Sinne der vereinbarten Ziele in einem dynamischen Umfeld zu erbringen Flexibilität, Lösungsorientierung und Prozessaffinität und ein ausgeprägtes Maß an Qualitäts-, Kunden- und Zielorientierung Verhandlungssichere Englischkenntnisse in Wort und Schrift sowie gute IT-Kenntnisse Ein starkes Team, das zum medizinischen Fortschritt beiträgt Ein spannendes und innovatives Umfeld mit zahlreichen Gestaltungs- und Entwicklungsmöglichkeiten Teil des japanischen Konzerns Showa Denko Materials Co., Ltd 13 Gehaltszahlungen Betriebliche Altersvorsorge, Vermögenswirksame Leistungen Zuschuss zur Kinderbetreuung Diverse Mitarbeitervergünstigungen
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Project Manager (f/m/d) Drug Product Development for Biopharmaceuticals

Do. 02.12.2021
München
Coriolis Pharma is a globally operating independent service provider for formulation research and development of for a large variety of different (bio)pharmaceutical molecules, including proteins, peptides, nucleic acids, ATMPs (in particular viral vectors for gene delivery), GMOs, vaccines and virus(-like) particles. An interdisciplinary team of highly qualified scientists with many years of experience in the development of (bio)pharmaceuticals supported by an expert scientific advisory board provides cutting-edge service and know-how related to the formulation development of biopharmaceuticals. At our company, we pursue one goal every day: the advancement of medicines to cure people. Our expanding company currently employs about 140 people at two sites. For our Team in Munich we are currently looking for Project Manager (f/m/d) Drug Product Development for Biopharmaceuticals Take over the responsibility to lead and manage drug product development projects with focus on formulation development (liquid and/or lyophilized) for biopharmaceuticals and vaccines for clients Take over the lead in the communication with the client (first point of contact) and internally with other project team members and involved units at Coriolis Ensure that relevant resources are embedded into the project and that project-related decisions are based on state-of-the-art scientific principles Perform project planning, coordination, execution (supported by project team members for laboratory work) and resource management Ensure timely delivery of projects within budget, scope and desired quality Ensure that project deliverables, i.e. experimental plans, experimental data, data presentations and reports are prepared timely and according to the required quality standards Take over the responsibility for interpretation of data and the drawing of final conclusions; compile data presentations and reports Act in the role as a drug product development expert (individually with a different focus based on your experience) and provide support to scientists and junior scientists University degree in pharmacy, (bio)chemistry, biology, or related field, PhD beneficial A mininum of 4-5 years of relevant working experience Proven ability in leading drug product development programs Profound expert / scientific knowledge in liquid and/or lyophilization formulation development and analytical characterization of biophamaceuticals Team player with strong motivation and inter-personal skills Open for new ideas and tasks, can-do attitude and hands on mentality Excellent verbal and written communication skills in English and German As a Project Manager, you will join a highly motivated, interdisciplinary team performing contract research and development for clients from the (bio)pharmaceutical industry worldwide. We offer you diversified and challenging areas of responsibilities in our innovative company. We actively support your personal development (project management, technical, scientific and personal skills) tailored to your individual development plan. Beyond that Coriolis offers a variety of benefits and team activities to its employees. Coriolis Pharma is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, gender, color, disability, religion/belief, sexual orientation, marital status  or age.  We value diversity at our company! Due to the current events concerning COVID-19, Coriolis Pharma has implemented different measures to ensure the health and safety of our employees (Air filter in every office, free masks and disinfectants, flexible use of home office).
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Global Patient Safety (GPS) Senior Scientist (gn)

Do. 02.12.2021
Planegg
MorphoSys’ mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich! We would like to fill the following vacancy as soon as possible: Global Patient Safety (GPS) Senior Scientist (gn) You will be a core member of the relevant product-specific Safety Management and Review Team(s) (SMART) Provide technical safety expertise to ensure the scientific integrity and quality of all relevant safety-related clinical development and post-marketing activities and deliverables Responsible for but not exclusively: All relevant safety-related clinical trial activities and deliverables, including writing relevant sections of clinical trial protocols and related documents (member of the respective cross-functional Clinical Trial Teams) Safety signal management Benefit-risk evaluations Definition and implementation of pharmacovigilance and risk minimisation activities Health Hazard Evaluations for Product Quality Concerns Responses to safety-related questions from health authorities Provide state-of-the-art safety scientific methodology for safety data analysis, visualization and interpretation, collaborating closely with biostatistical colleagues Provide technical / scientific expertise to the development and implementation of new tools, e.g. safety data analysis and visualization tools Present safety-related data, information and messages to internal and external audiences as required Demonstrate knowledge of, and ensure compliance with company guidelines, policies and procedures and be able to demonstrate this during health authority inspections A higher qualification (Masters degree or PhD or equivalent) in a bioscience subject, or pharmacy Professional Experience: Good understanding of the pharmaceutical industry Sound knowledge and understanding of industry and pharmacovigilance legislation, including ICH-GCP and clinical safety guidelines, EU Clinical Trials Regulation and EMA GVP Modules, and FDA clinical safety and risk management guidance, and the need for compliance with these Extensive experience in pharmacovigilance/patient safety, plus / minus clinical research Close cross-functional collaboration, including with Biostatistics, Regulatory Affairs, Clinical Development, Medical Affairs, C&QA, Non-clinical drug safety, CMC Personal Skills: Fluent spoken and written professional English Excellent communication skills, oral and written – ability to present information clearly and concisely Strong team-working skills – working across cultural and functional boundaries Able to prioritise, adapt rapidly to changes in priorities, and manage multiple situations / issues, remaining calm and delivering under pressure Strategic thinking Problem-solving and decision-making ability Creative working in X-functional teams Open and appreciative corporate culture Multicultural environment Working in an attractive, high-quality equipped building with restaurant Free sports and language courses
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Trainerin für Apothekenpersonal (m/w/d) PTA im Schulungsaußendienst

Do. 02.12.2021
Frankfurt am Main, Mainz, Karlsruhe (Baden), Kassel, Hessen, Mannheim, München, Nürnberg, Saarbrücken, Stuttgart
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. IQVIA has 80,000 employees in more than 100 countries, all committed to making the potential of Human Data Science a reality.Join us on our exciting journey! Trainerin für Apothekenpersonal (m/w/d)PTA im Schulungsaußendienst Du bist Berater mit Leib und Seele und kommst aus dem Apothekenumfeld? Du möchtest Wissen weitergeben und liebst es, zu inspirieren? Dann bist Du bei Aposphäre, dem führenden Apothekenschulungsaußendienst, genau richtig! Als innovativer Partner der Pharmaindustrie unterstützen wir Apotheken bei sämtlichen Herausforderungen am Point of Sale – von kreativen Maßnahmen für mehr Abverkauf bis zu intensiven Schulungen und Coachings zur Steigerung der Beratungskompetenz. Mit unserer Expertise erhöhen wir maßgeblich den Absatz renommierter OTC-Produkte und stehen dabei stets im direkten Austausch mit unseren Partnern. Für unser engagiertes Team suchen wir zum nächstmöglichen Zeitpunkt: PTAs als Trainer für Apothekenpersonal in unserem festangestellten Schulungsaußendienst. Wir suchen bundesweit mit den Schwerpunkten auf den Gebieten Frankfurt am Main/Mainz, Karlsruhe, Kassel, Mannheim, München, Nürnberg, Saarbrücken, Stuttgart zum nächstmöglichen Zeitpunkt! Als Apotheken-Trainer gestaltest Du an der Schnittstelle Beratung – Training – Vertrieb aktiv die Pharmawelt von morgen mit und bringst Deine innovativen Ideen ein. Umfassende Betreuung von Top-Apotheken in Deinem Schulungsgebiet Eingehende Schulung des Apothekenpersonals zu den renommierten OTC-Produkten und Arzneimitteln unserer Auftraggeber Gestaltung und Durchführung von Präsentationen sowie Produktschulungen für Apotheken-Teams Unterstützung der Apotheken bei Werbeaktionen und -kampagnen – von der Konzeption bis zur Umsetzung Kundenmanagement vom Erstkontakt bis zur langfristigen Begleitung unserer Partner Abgeschlossene Ausbildung als PTA oder mindestens eine gleichwertige Qualifikation Mindestens zwei Jahre Berufserfahrung im Apothekenumfeld in einer der oben genannten Positionen Kommunikatives, natürliches Auftreten sowie starke vertriebliche Kompetenzen Ausgeprägtes Organisationstalent, Zuverlässigkeit und Flexibilität Umfangreiches Fachwissen über Arzneimittel medizinische Produkte sowie der Wunsch, dieses stetig weiter auszubauen und weiterzugeben Sehr gute rhetorische Fähigkeiten runden Dein Profil ab Abwechslungsreiche Tätigkeiten mit viel Kontakt zu Menschen und der Möglichkeit, Neues zu lernen Intensive Schulungs- und Einarbeitungsphase Mitarbeit bei übergreifenden Projekten zur Weiterentwicklung unseres Angebotsportfolios Attraktives Gehalt sowie Dienstwagen, iPhone und iPad – auch zur privaten Nutzung Einen Zuschuss zur betrieblichen Altersvorsorge
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Senior Scientist (w/m/d) Lyophilized Drug Product Development for Biopharmaceuticals

Do. 02.12.2021
Planegg
Coriolis Pharma is a globally operating independent service provider for formulation research and development of for a large variety of different (bio)pharmaceutical molecules, including proteins, peptides, nucleic acids, ATMPs, GMOs, vaccines and virus(-like) particles. An interdisciplinary team of highly qualified scientists with many years of experience in the development of (bio)pharmaceuticals supported by an expert scientific advisory board provides cutting-edge service and know-how related to the formulation development of biopharmaceuticals. At our company, we pursue one goal every day: the advancement of medicines to cure people. Our expanding company currently employs about 140 people at two sites. Senior Scientist (w/m/d) Lyophilized Drug Product Development for Biopharmaceuticals Contribute scientific expertise Cross functional support for projects teams at Coriolis working on lyophilization projects Provide strategic scientific and technological input into client projects, based on profound experience, best practice and risk mitigation in the field of lyophilization (formulation and process) Give input into experimental planning, support the compilation of workplans and reports Lead, perform and support troubleshooting activities Pass on knowledge to team members and ensure continuous improvement of scientific skills of team members Give internal lectures and trainings at Coriolis Drive implemention of novel technologies and strenghthen scientific expertise in the area of lyophilization Project management Take over the responsibility as project leader, working on client projects with focus on lyophilization of biopharmaceuticals and ATMPs (formulation and lyophilization process development) Project planning, coordination, execution and resource management Ensure that relevant resources are embedded into the project and that project-related decisions are based on state-of-the-art scientific principles University degree in (bio)chemistry, biology, medical sciences pharmacy or related field, PhD beneficial A mininum of 10 years relevant experience Strong scientific background and experience in the field of lyophilization technology Experiences in (bio)pharmaceutical formulation development and characterization Experience in lyophilization under (BL)S2 is of advantage Team player with strong motivation and inter-personal skills Open for new ideas and tasks, can-do attitude and hands on mentality Excellent verbal and written communication skills in English and German  As a Senior Scientist, you will join a highly motivated, interdisciplinary team performing contract research and development for clients from the (bio)pharmaceutical industry worldwide. We offer you diversified and challenging areas of responsibilities in our innovative company. We actively support your personal development (technical, scientific and personal skills) especially by training on relevant techniques for characterization of (bio)pharmaceuticals. Beyond that Coriolis offers a variety of benefits and team activities to its employees.
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Pharmacovigilance Operations Lead (m/f/x)

Mi. 01.12.2021
München
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For our headquarter in Munich we are seeking highly qualified candidates to fill the position Pharmacovigilance Operations Lead (m/f/x) Leads the Pharmacovigilance (PV) Operations team at Daichi Sankyo Europe which focuses on individual case safety report (ICSR) handling from post-marketing. PV Operations includes all aspects of case processing in the safety database, ensuring the AE collection process (i.e. Spontaneous, Solicited, Post-Marketing Study sources), regulatory reporting requirements, vendor management for case processing and its quality and compliance. The position is closely working with the global PV operations team (US, Japan) and global case processing vendors and act as primary contact among CSPV and other functions for PV operational activities and assists in management of PV audit/inspection. Contributes to the global PV Operations strategy and decision making via the global PV operations team. The position reports to the Head of the DSE CSPV department (EU-QPPV) as well as the Global PV operations Lead. Roles and Responsibilities: ICSR handling Oversees the system for ICSR collection, processing, reconciliation and reporting, including associated quality and training activities to ensure regulatory timelines and global standards are met. This includes AE report intake, Case processing, Follow-up requests, ICSR reporting, ICSR quality control, SAE reconciliation, Partner reconciliation, Case processing vendor management, Workflow management. Ensures that all safety reports received are processed and reported according to regulatory requirements and company procedures. Supports and/or provides internal training on ICSR activities as applicable. Prepares and maintains company procedures around case management activities and assists in management of PV audit/inspections. Case processing CRO management Manages, communicates and provides trainings on ICSR activities, safety procedures and processes on a regular basis with case process service providers and oversees their quality of work. Develops and monitors case processing KPIs/metrics, and takes appropriate actions with the case process service providers to achieve continuous improvement. Study start up Oversees and works with clinical study teams, develops and maintains study- specific SAE Flow Plans/Safety Management Plans along with Product Safety Physicians to ensure all required safety information to be collected following the regulations and medical requirements. Facilitates and ensures communication with functions involved with receiving, investigating, or reporting AEs; supports cross-functional study and program teams. Develops SAE Reconciliation Plan and oversees the reconciliation process. Reviews study documents on behalf of PV Operations team (Protocol, Data Management Plan, PV Agreements/Safety Data Exchange Agreements), supports setting up electronic data capture (EDC) systems for AE collection and reporting process to the Health Authorities, Affiliates and Partners (e.g. Configuration of reporting rules in the safety database). People/Team Management Leads, manages and mentors staff and assigns responsibilities as appropriate to maximize the team outputs and provides opportunities for individual growth. Prepares individual development plans for the members within the function and supports the execution. Bachelor’s degree at minimum required; Master, PhD preferred Minimum 8 years of experience in PV with an advanced degree; 10 years of experience with bachelor’s degree Leadership skills, Positive attitude Strong PV regulation knowledge Knowledge of international and European PV laws Experience in case management Strong communication skills Fluent business English (oral and written) Relocation to Munich preferred Competitive Pay Work-Life-Balance Growth and Development Health and Family Working at Daiichi Sankyo: At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.
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MTLA (m/w/d)

Mi. 01.12.2021
München
Das LMU Klinikum ist eines der größten und leistungsfähigsten Universitätsklinika in Deutschland und Europa. 49 Fachkliniken, Abteilungen und Institute mit einer exzellenten Forschung und Lehre ermöglichen eine Patientenversorgung auf höchstem medizinischen Niveau. Hieran sind rund 11.000 Mitarbeiterinnen und Mitarbeiter beteiligt. Die Abteilung für Transfusionsmedizin, Zelltherapeutika und Hämostaseologie am Campus Großhadern sucht für das LfIMD (Labor für Immungenetik und Molekulare Diagnostik) zum nächstmöglichen Zeitpunkt, in Vollzeit, einen MTLA (m/w/d)Das LfIMD versorgt alle Patienten des LMU Klinikums, der Kliniken rechts der Isar, Augsburg und Schwabing sowie weiterer externer Einsender aus medizinischen Versorgungszentren und niedergelassenen Praxen mit dem Gesamtspektrum der immungenetischen und transplantationsimmunologischen Diagnostik. Hierbei handelt es sich um Patienten vor bzw. nach der Transplantation solider Organe (Herz, Lunge, Leber, Pankreas, Niere bzw. Dünndarm) oder um Patienten vor der Transplantation von Knochenmark bzw. hämatopoetischer Stammzellen. Im Rahmen der Transplantation solider Organe ist eine enge Zusammenarbeit mit der Deutschen Stiftung Organspende (DSO) und Eurotransplant über 24 Stunden an sieben Tagen der Woche durch eine Rufbereitschaft erforderlich. Ihre Aufgaben: Bestimmung der Humanen Leukozyten-Antigene (HLA) mit unterschiedlichen molekulargenetischen Techniken Nachweis lymphozytärer Antikörper mit verschiedenen Methoden Tätigkeiten im ELISpot-Labor (Forschungsbereich) Kommunikation mit Einsendern aus ambulanten Einrichtungen und Kliniken Auswertung der Analyseergebnisse sowie Befunderstellung mittels Labor-EDV Teilnahme am 24-Stunden-Rufdienst für die Deutsche Stiftung Organtransplantation und Eurotransplant Examinierter MTLA / Medizinisch-Technischer Laboratoriumsassistent (m/w/d) nach deutschem Recht Berufserfahrung wünschenswert, aber keine Voraussetzung Basiskenntnisse in der EDV wünschenswert Flexibilität und Teamfähigkeit Rufdienstvergütung Ballungsraum-Zulage Zusatzversorgung VBL Vermögenswirksame Leistungen Fort- und Weiterbildungen, Betriebliche Altersvorsorge, Kinderbetreuungsangebote, Jobticket, Vergünstigungen und Personalwohnraum
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Lead of Pharmacovigilance Database Management & Analytics (m/f/x)

Mi. 01.12.2021
München
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For our headquarter in Munich we are seeking highly qualified candidates to fill the position Lead of Pharmacovigilance Database Management & Analytics (m/f/x) Leads the Pharmacovigilance Database Management and Analytics team at Daichi Sankyo Europe which is responsible for the oversight and management of the Global Safety Database and Data Analytic tools (e.g. PV reporting and analytic solutions) to meet industry standards and ensures these are appropriately configured to comply with Health Authority requirements globally including system validation, configuration and training activities. This team is also responsible for data analytics and generation of pharmacovigilance reports as well as supporting interfaces for appropriate data exchange (e.g. sharepoint, box). The position is closely working with global teams (US, Japan) and system support vendors and is involved in the global strategy and decision making on PV system/technology related activities. The position reports to the Head of the DSE CSPV department (EU-QPPV) locally as well as the PV DB Management and Analytics global function Lead. Roles and Responsibilities: Management of Global Safety Database and Data Analytic tool Oversees all PV systems and involve in strategy dicussion on global PV system/technology related activities which includes new system installation, configuration and integration with different sytems. Identifies and develops new systems/databases to meet future business needs and expectations of Regulatory Authorities. Ensures the system support vendors are qualified, high performing and motivated to achieve the business objectives. Implements advenced technologies (e.g. E2b import, Axway configuration) and process automation for business process improvement. Works with Medical, PV operation and Regulatory Intelligence teams and ensures that all safety database configurations are well-maintained. Manages reported issues on Systems including troubleshooting, liaising with IT Application Support team and helpdesk. Ensures appropriate company procedures are in place for timely and accurate reporting of PV information for expedited, aggregate and ad-hoc reporting needs and assists in management of PV audit/inspections. Data Analytics/PV reports Ensures the team provides PV reports as per the request of the PV subject matter experts (e.g. Safety surveillance/Medical assessment, Health Authority & Partner requests, Periodic reports, KPIs/Metrics report, Audit/Inspection readiness/Reconciliation) in a regular, timely and automated manner. Ensures availability of non-standard safety reports, which enable PV subject matter experts to find solutions with complex requirements/assessments. People/Team Management Leads, manages and mentors staff and assigns responsibilities as appropriate to maximize the team outputs and provides opportunities for individual growth. Prepares individual development plans for the members within the function and supports the execution. Bachelor’s degree at minimum required; Master, Ph. D preferred Minimum 8 years of experience in PV with an advanced degree; 10 years of experience with a bachelor’s degree Experience with PV tools, handling Database structure and validation ( i.e. Oracle, Argus or ARISg) is required. Knowledge around programing (e.g. SAS, SQL) is preferred Leadership skill, Positive attitude, Customer focus Possesses strong PV regulation knowledge Knowledge of International and European PV laws Strong communication skills Fluent business English (oral and written) Relocation to Munich preferred Competitive Pay Work-Life-Balance Growth and Development Health and Family Working at Daiichi Sankyo: At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.
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Executive Quality Advisor (m/w/d) - Life Science Quality Management

Di. 30.11.2021
Düsseldorf, Berlin, Frankfurt am Main, München, Stuttgart
Making an impact that matters. Unser Anspruch ist, jeden Tag das zu tun, was wirklich zählt. Mit unserem breiten Leistungsspektrum – von Audit & Assurance, Risk Advisory über Tax & Legal bis Financial Advisory und Consulting – unterstützen wir Kunden auf einzigartige Weise. Wir setzen neue Maßstäbe, liefern innovative Denkansätze und ermöglichen nachhaltiges Wachstum. Wir fördern unsere hochqualifizierten Mitarbeitenden mit ihren verschiedensten Talenten, sodass sie mit uns mehr erreichen. Im Business Risk Advisory unterstützen wir unsere Kund:innen bei der Identifizierung und Vorbeugung potenzieller Risiken in allen Geschäftsbereichen. Dabei betrachten wir finanzielle, technologische und geschäftsrelevante Risiken, um den Unternehmenserfolg langfristig zu sichern. Im Team von Regulatory & Legal Support entwickeln Sie für unsere Kund:innen individuelle Lösungsansätze zur Bewältigung aktueller Herausforderungen, die aus der Digitalisierung und Entwicklung sowie Implementierung von Risikomodellen branchenübergreifend resultieren. Dabei beraten Sie zu Themen der optimalen organisatorischen und prozessualen Ausgestaltung der Geschäftsmodelle und der Compliance von Unternehmen in regulierten Branchen.   Für unsere Teams an den Standorten Düsseldorf, Berlin, Frankfurt (Main), München und Stuttgart suchen wir engagierte Verstärkung. Die Digitalisierung in einem regulierten Umfeld wie die Life Science Industrie wird nur ganzheitlich gelingen, wenn wir das Herzstück, das Qualität Management System, zu einem digitalen intelligenten Informationsmanagement transformieren. Dieser Herausforderung nehmen wir uns an. Als Kernmitglied des cross-disziplinären Entwicklungsteams verantworten Sie die regulatorische Sicherstellung digitaler Assets und Managed Services für ein digitales Qualitätsmanagementsystem Sie leiten die regulatorische Betrachtung/Impact Analyse/Risikobewertung neuartiger digitaler Lösungen und Haftungsfragen und leiten den Austausch mit Behörden Sie beraten das Team über den aktuellen Stand der regulatorischen Anforderungen mit einem Fokus auf Data Integrity und Computerized System Validation Als Quality Advisor in den Umsetzungsprojekten verantworten Sie die regulatorische Beratung in der Anwendung innovativer Technologien und leiten Quality Maturity/Performance Assessments Mit Ihrer regulatorischen Expertise und Ihrem Industrie Wissen tragen Sie maßgeblich zu einer erfolgreichen Go-to-Market Strategie bei Als „Ambassador“ sind Sie aktive:r Netzwerker:in in der Life Science Industrie (inklusiver entsprechender Publikationen/Präsentationen) und fungieren als Meinungsbilder:in und aktive:r Gestalter:in im Austausch mit Expertengremien und Behörden Sie überschauen die weltweiten regulatorischen Trends und treiben aktiv den Deloitte internen Wissensaustausch voran Erfolgreich abgeschlossenes Hochschulstudium (Master Degree) der Fachrichtung Pharmazie, Medizin, Ingenieurswissenschaften oder vergleichbarer Naturwissenschaften. Idealerweise verfügen Sie ergänzend über eine Business Zertifizierung (MBA) Exzellentes, breites regulatorisches Wissen mit Fokus auf Data Integrity, Computerized System Validation in der digitalen Anwendung Mindestens 15 Jahre Berufserfahrung in Senior Quality Positionen in der Life Science/Healthcare Industrie oder Behörden, davon mehrjährige Erfahrung in der Produktion in QA/QC, Quality Management System, und/oder Audit Management Exzellentes analytisches Denkvermögen, sowie ausgeprägte, cross-disziplinäre Teamorientierung Sehr gute Kommunikationsfähigkeiten, um komplexe Zusammenhänge kundenspezifisch, präzise und überzeugend darzustellen Sehr hohe Verhandlungskompetenz (auch mit Behörden) und ausgeprägte Lösungsorientierung Gute MS-Office- Anwender-Kenntnisse Sehr gute Englisch- und Deutschkenntnisse Flexibilität und Reisebereitschaft Neben einer angenehmen, kollegialen Atmosphäre bieten wir Ihnen ein chancenreiches, internationales Arbeitsumfeld. Bei uns gelten flache Hierarchien und ein Prinzip der offenen Tür. Wir bieten eine Vielzahl von Entwicklungsprogrammen, insbesondere für das Senior Management. Hierdurch unterstützen wir aktiv Ihre berufliche und persönliche Entwicklung. Ein weiterer Pluspunkt: Ihre leitende Mitarbeit an einem neuartigen Quality Management System für die Life Science Industrie, und die damit verbundene Reputation, stellen eine einzigartige Karrierechance für Sie dar.
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