Senior Drug Safety Manager (m/w/d)

Standort: München, DeutschlandAnstellungsart: FestangestelltKategorie: PharmacovigilanceEintrittsdatum: 04.03.2025Veröffentlicht: 2026-01-13Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort.Senior Drug Safety Manager (m/w/d)Post Marketing PharmacovigilanceAssignementsIndependently manage a third-party pharmacovigilance vendor in an outsourced PV post-marketing setting including Signal Management and QPPV ServicesOversight, Monitoring and Contribution to post-marketing aggregate reporting (PAER, PBRER, PSUR) in US and EMA areaOrganize and contribute to preparation of internal Safety Review Committee Meetings for Signal Management and follow-up on outcome and conclusionsOrganize, oversee and review quarterly PSMF updatesOversee and contribute to XEVMPD registration updatesOversee and manage EMA/EVweb accounts and registration of our client and vendor staffOversight, Monitoring and Contribution to post-marketing aggregate reporting (PAER, PBRER, PSUR) in the US and EMA regionOversight of Medical Information Center Services including Inquiry Reconciliation Management and budget oversightProvide sponsor oversight of ICSR/SAE processing by an outsourced vendor including the monitoring of reporting compliance (by KPIs) and ensuring a high standard of case narrative writing by quality reviewCollaborate with Medical Affairs personnel to monitor and maintain high quality of SAE/ICSR reportingEnsure vendor surveillance with regards to cost control, on time completion of outsourced activities and on-budget delivery of pharmacovigilance servicesRepresent the Drug Safety Department in program teams and in external vendor team meetingsProactively drive cross-functional activities and work with external partners to maintain high quality safety processingEnsure compliance with SOPs, GCP, GVP and relevant regulatory environment of activities and documentationParticipate in and support internal/external inspections and auditsRequirementsBachelor’s or Masters’ degree in Life Science/Pharmacy/Medical Sciences, or other equivalent experience/educationAt least 2-3 years experience in a post-marketing pharmacovigilance setting.Good understanding and working knowledge of safety reporting and regulatory environment in a PV US/EMA post-marketing settingKnowledge of Safety Database handling (e.g., Argus) is advantageousExperience with immunologically active pharmaceutical products would be advantageousAbility to work harmoniously within international cross-functional teams, engage in open, constructive and continuous dialogue with internal staff and external partnersAbility to plan, organize and manage multiple projects and priorities simultaneouslyHighly motivated, self-driven, dependable, and solution-orientedEffective communication and presentation skillsFluent in written and verbal business English; fluency in German desirableFamiliar with MS Word, Excel and PowerPointSalary & Home-OfficeSalary Range: 80.000 - 100.000 gross p.a.Home-Office: 10 days per month which you can set freely if you are living in Munich, if you are located in other cities a more flexible rule can be agreed individuallyLea Stolle, Senior Recruitment Specialist is delighted to get in touch to discuss the role, our cllient and, of course, questions that you may have. Tel.: +49 441 21879-42, e-mail to: lea.stolle@optares.de