Beschreibung
Senior Pharmacovigilance Scientist (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- The Senior Pharmacovigilance (PV) Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and other PV Scientists
- Authors and leads PV input to safety documents and regulatory reports
- Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate
- Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products
- Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports
- Leads the cross-functional Safety Strategy and Management Team (SSaMT) for large and/or complex projects
- Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders
- Leads and authors the Reference Safety Information (RSI) for multiple and/or complex development products and collaborates with GSP and Clinical representatives as needed
- Authors/provides strategic input or oversight for multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines
- Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts
- Trains and mentors junior members of the team
Main qualifications
- A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
- Advanced knowledge of PV regulations
- Intermediate understanding of epidemiology, preferred
- Fluent in written and verbal English
Main advantages:
- A very renowned company
- A highly motivated team and an open way of communication
- Interesting tasks in a multinational environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Nadja Jacqueline Sigwart
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