Pharmacovigilance Physician
On-siteFrederick, Maryland, United States
Job Summary
Review and assess serious adverse events, performing causality and expectedness assessments while leading benefit-risk evaluations and signal detection activities. Support expedited regulatory reporting, participate in DSMBs and safety review committees, and review protocols, Investigator Brochures, and informed consent forms. Contribute to IND safety reports, annual reports, DSURs, and safety communications, providing medical safety consultation to project teams and supporting risk management planning. Participate in regulatory inspections and audits. Requires MD degree, unrestricted U.S. license, board certification, and 10+ years in drug safety.
Required Qualifications
- Doctor of Medicine (MD) degree
- Current unrestricted U.S. medical license
- Board Certified Physician
- Minimum 10 years of clinical or pharmaceutical industry experience
- Extensive drug safety and pharmacovigilance experience
- Strong knowledge of FDA and ICH pharmacovigilance requirements
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