We have just received instruction from our client, a global who are known as a leader in their field, to search for a Global Pharmacovigilance Drug Safety Risk Physician.
This role reports into Global Head PV RISK management, which reports into VP & Global Head Quality & Pharmacovigilance.
- Drug Safety
- Serious clinical trial experience
- Clinical Development
- Propose measures aiming at minimizing risks during clinical development; release. Update the Development Risk Management Plans (DRMPs).
- Interact with internal and external stakeholders to ensure monitoring of safety profile, signal validation and signal evaluation, and propose appropriate risk management and risk minimization measures.
- Review/provide input to Aggregate Reports (DSUR, PSUR, PBRER) and Risk Management Plans (RMP).
- Contribute to answers to safety-related questions from Regulatory agencies.
- Medical doctor
- At least 5 years pharmacovigilance experience at an international level.
- Significant experience of international clinical development and post marketing regulations applicable to drugs.
- Strong knowledge of the global pharmacovigilance and safety requirements for non-clinical and clinical development, registration process and post-marketing.
- Act with minimum oversight in most circumstances as well as provide key input to difficult or sensitive projects.