Senior Medical Director, Pharmacovigilance and Safety
Core
Lead medical and scientific safety oversight for investigational biologics targeting chronic skin diseases, ensuring compliance with global regulations and protecting participant safety.
Role type
Senior Medical Director, Pharmacovigilance and Safety
Builds
Safety regulatory documents, aggregate safety reports, and risk management plans for clinical development.
Domain
Biotechnology / Dermatology / Pharmacovigilance
Required skills
Global pharmacovigilance regulations, safety signal detection, medical review of adverse events, vendor management, regulatory correspondence, safety data analysis, clinical judgment
Preferred skills
Experience with safety surveillance systems (Argus, MedDRA, Veeva Vault), leadership of safety governance committees
Technologies
Argus, MedDRA, Veeva Vault
Responsibilities
Develop product safety surveillance strategies and risk-mitigation measures; oversee expedited safety reporting and medical review of ICSRs/SUSARs; lead aggregate safety reviews and chair safety governance committees; prepare regulatory documents like Investigator's Brochures and Risk Management Plans; represent the company in FDA and global regulatory meetings; oversee pharmacovigilance vendors and inspection readiness.
Seniority
Senior, hands-on IC with leadership responsibilities
