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Pharmazie: 1 Job in Nidda

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Pharmazie

Senior Manager Pharmacovigilance (f/m/d)

So. 05.09.2021
Friedrichsdorf, Taunus
Do you want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity. PharmaLex is one of the leading service companies for the global pharmaceutical industry and is specialized in all aspects of drugs and medical devices from development to approval as well as product maintenance. The success of our company grows with the excellent expertise and the high motivation of our employees. If for you, your profession is not only a job but a mission too and you enjoy working with people and in teams, then you are highly welcome to join us. As of now we would like to strengthen our successful team (in Friedrichsdorf, Germany or home-based) and are looking for a: Senior Manager Pharmacovigilance (f/m/d) Consult clients in all matters related to Pharmacovigilance Plan, set-up, improve and maintain PV systems for clients Take over QPPV and GPO (Graduated Plan Officer (Stufenplanbeauftragte/r)) roles for clients Prepare and review of PV quality management documents (e.g. PSMFs, SOPs, Wis, SDEAs) Review safety reports (e.g. PSURs, RMPs) as Part of the QPPV oversight Contribute to monitoring product safety profiles through signal detection as well as safety issue review Screen product quality complaints regarding safety-relevant issues Answer safety-relevant enquiries from regulatory authorities Participate in GVP audits and inspections Instruct and train junior members of the team in all Pharmacovigilance aspects Master’s Degree in medicine, pharmacy or natural science Ideally several years of experience in Pharmacovigilance and related aspects Detailed knowledge of the applicable legislation (e.g. GVP, AMG) Able to operate as Qualified Person for Pharmacovigilance (QPPV) and graduated Plan Officer level Experience with management and steering of projects Strong interpersonal and organizational skills as well as a team-oriented approach High sense of responsibility and self-motivation Highly service orientated Diverse and challenging tasks paired with methodological knowhow Cooperative partnership in truly interdisciplinary teams Chance to take ownership and responsibility Flexible working hours Continuous development opportunities through knowledge exchange
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