Patient Safety, Medical Director
Core
Provide medical safety expertise and pharmacovigilance for assigned products to optimize patient safety and ensure global regulatory compliance.
Role type
Senior Medical Director (Patient Safety/Pharmacovigilance)
Builds
Safety assessments, risk management strategies, and regulatory responses for marketed and in-development products.
Domain
Biotechnology / Pharmacovigilance / Clinical Safety
Required skills
Pharmacovigilance, clinical safety, benefit-risk assessment, regulatory agency interactions, ICSR case review, aggregate safety analysis, protocol development, statistical analysis, medical evaluation of toxicology/non-clinical data, SOP development.
Preferred skills
Data management systems, pharmacoepidemiology, strategic planning, cross-functional team leadership.
Technologies
DSUR, PSUR, PADER, NDA/MAA, RMP, REMS, IDMC Charter, IB, ICF.
Responsibilities
Monitor benefit-risk profiles, lead safety teams, analyze clinical safety signals, prepare periodic safety reports, evaluate safety data from trials and literature, guide staff on adverse event processing.
Seniority
Senior, hands-on IC