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Senior Drug Safety Manager (m/w/d) (DE)
[6688]
Our 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 Pharmacovigilance Assignements ·Independently manage a third-party pharmacovigilance vendor in an outsourced PV post-marketing setting including Signal Management and QPPV Services ·Oversight, Monitoring and Contribution to post-marketing aggregate reporting (PAER, PBRER, PSUR) in US and EMA area ·Organize and contribute to preparation of internal Safety Review Committee Meetings for Signal Management and follow-up on outcome and conclusions ·Organize, oversee and review quarterly PSMF updates ·Oversee and contribute to XEVMPD registration updates ·Oversee and manage EMA/EVweb accounts and registration of our client and vendor staff ·Oversight, Monitoring and Contribution to post-marketing aggregate reporting (PAER, PBRER, PSUR) in the US and EMA region ·Oversight of Medical Information Center Services including Inquiry Reconciliation Management and budget oversight ·Provide 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 review ·Collaborate with Medical Affairs personnel to monitor and maintain high quality of SAE/ICSR reporting ·Ensure vendor surveillance with regards to cost control, on time completion of outsourced activities and on-budget delivery of pharmacovigilance services ·Represent the Drug Safety Department in program teams and in external vendor team meetings ·Proactively drive cross-functional activities and work with external partners to maintain high quality safety processing ·Ensure compliance with SOPs, GCP, GVP and relevant regulatory environment of activities and documentation ·Participate in and support internal/external inspections and audits Requirements ·Bachelor’s or Masters’ degree in Life Science/Pharmacy/Medical Sciences, or other equivalent experience/education ·At 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 setting ·Knowledge of Safety Database handling (e.g., Argus) is advantageous ·Experience with immunologically active pharmaceutical products would be advantageous ·Ability to work harmoniously within international cross-functional teams, engage in open, constructive and continuous dialogue with internal staff and external partners ·Ability to plan, organize and manage multiple projects and priorities simultaneously ·Highly motivated, self-driven, dependable, and solution-oriented ·Effective communication and presentation skills ·Fluent in written and verbal business English; fluency in German desirable ·Familiar with MS Word, Excel and PowerPoint Salary & Home-Office ·Salary 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 individually Tilman Grumbd, Managing Partner of Optares is delighted to get in touch to discuss the role, our cllient and, of course, questions that you may have. Tel.: +49 441 21879-34, +40 175 5501950, e-mail to: tilman.grumbd@optares.de
- Independently manage a third-party pharmacovigilance vendor in an outsourced PV post-marketing setting including Signal Management and QPPV Services
- Oversight, Monitoring and Contribution to post-marketing aggregate reporting (PAER, PBRER, PSUR) in US and EMA area
- Organize and contribute to preparation of internal Safety Review Committee Meetings for Signal Management and follow-up on outcome and conclusions
- Organize, oversee and review quarterly PSMF updates
- Oversee and contribute to XEVMPD registration updates
- Oversee and manage EMA/EVweb accounts and registration of our client and vendor staff
- Oversight, Monitoring and Contribution to post-marketing aggregate reporting (PAER, PBRER, PSUR) in the US and EMA region
- Oversight of Medical Information Center Services including Inquiry Reconciliation Management and budget oversight
- Provide 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 review
- Collaborate with Medical Affairs personnel to monitor and maintain high quality of SAE/ICSR reporting
- Ensure vendor surveillance with regards to cost control, on time completion of outsourced activities and on-budget delivery of pharmacovigilance services
- Represent the Drug Safety Department in program teams and in external vendor team meetings
- Proactively drive cross-functional activities and work with external partners to maintain high quality safety processing
- Ensure compliance with SOPs, GCP, GVP and relevant regulatory environment of activities and documentation
- Participate in and support internal/external inspections and audits
Requirements
- Bachelor’s or Masters’ degree in Life Science/Pharmacy/Medical Sciences, or other equivalent experience/education
- At 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 setting
- Knowledge of Safety Database handling (e.g., Argus) is advantageous
- Experience with immunologically active pharmaceutical products would be advantageous
- Ability to work harmoniously within international cross-functional teams, engage in open, constructive and continuous dialogue with internal staff and external partners
- Ability to plan, organize and manage multiple projects and priorities simultaneously
- Highly motivated, self-driven, dependable, and solution-oriented
- Effective communication and presentation skills
- Fluent in written and verbal business English; fluency in German desirable
- Familiar with MS Word, Excel and PowerPoint
- Salary 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 individually
Tilman Grumbd