Medical Director, Immunology, Global Patient Safety
Core
Support the Product Safety Lead in ensuring product safety through pharmacovigilance surveillance, signal detection, validation, and assessment for pharmaceutical, biological, and drug-device combined products.
Role type
Senior Medical Director (Pharmacovigilance)
Builds
Medical safety assessments, regulatory responses, and risk management plans
Domain
Pharmaceutical / Biotechnology / Pharmacovigilance
Required skills
Pharmacology, Chemistry, Non-clinical toxicology, Clinical data analysis, Epidemiological information analysis, Technical document authorship, Regulatory guidance application, Aggregate safety data interpretation
Preferred skills
Master of Public Health (MPH)
Technologies
Pharmacovigilance systems, Regulatory databases
Responsibilities
Conduct safety surveillance for pharmaceutical/biological/drug-device products, Author key pharmacovigilance documents including risk management plans, Analyze and interpret aggregate safety data, Communicate safety analysis to cross-functional teams, Apply current regulatory guidance to safety activities
Seniority
Senior, hands-on IC