Global Safety Physician - Risk Management clinical development / Post market
- Experience Level
- Experienced (non-manager)
I’m partnered with a global pharmaceutical company in Germany looking for an expert in global safety and risk management to join their leading global PV team. This person will be responsible for both clinical development and post marketing products. We are currently supporting our client to spearhead a global expansion plan in this area.
Tasks & Responsibilities
- Develop/ contribute to proactive RM strategies for assigned compounds
- Plan, manage/ perform and monitor all PV activities for assigned drugs, including:
- Continuous monitoring and further development of the product safety profile
- Safety issue management
- Set-up of safety analyses in both postmarketing and clinical trial databases for monitoring
- Collaboration with Global Epidemiology and Medical Affairs on safety-focused clinical and epidemiologic studies
- Work cross functionally with various departments including clinical development to develop safety profile assessment strategies for developmental products.
- Provide interpretation of clinical trial safety data for clinical trial reports and submission documents. Be responsible for the drug safety related regulatory documents (e.g. PSURs, DSURs, RMPs, Clinical Overview Statements)
- Provide updates of the assigned drug’s safety profile to senior management as requested and recommend PV/ RM activities to decision making bodies
- Chair or be part of a internal multidisciplinary PV working group and represent Global PV in internal and external committees & bodies
- Medical doctor
- Several years of experience with PV
- Experience in Clinical Development and submissions
- Clinical development experience would be an asset
- Board certification/ broad clinical experience in either psychiatry, cardiology, respiratory, or Immunology/ rheumatology is desirable
- Fluent English, German speaking is advantageous
For more information regarding this position, reach out to Amy Jenkins at Barrington James.
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