Medical Director, Early Pipeline, Immunology, GPS
Core
Lead safety surveillance, signal detection, validation, assessment, and risk management for early development immunology products.
Role type
Senior Product Safety Team Lead (Medical Director)
Builds
Development Safety Update Reports (DSURs), risk management plans, pharmacovigilance documents
Domain
Pharmaceutical/Biotech, Immunology, Pharmacovigilance
Required skills
Medical leadership, safety data analysis, regulatory guidance interpretation, technical document authorship, risk management strategy, cross-functional communication
Preferred skills
Pharmacovigilance experience in pharma, preclinical/clinical/epidemiological data analysis
Technologies
None stated
Responsibilities
Lead safety surveillance and signal detection for early development products; Author key pharmacovigilance documents including DSURs; Interpret regulatory guidance for safety activities; Lead risk management strategy implementation; Communicate safety conclusions to governance bodies
Seniority
Senior, hands-on IC