Director, Global Clinical Safety
Core
Lead global clinical safety strategy, safety assessment, risk management, and pharmacovigilance for products in various stages of development.
Role type
Director, Global Clinical Safety
Builds
Safety surveillance activities and regulatory safety communications for assigned biopharmaceutical products
Domain
Biopharmaceuticals / Clinical Safety / Pharmacovigilance
Deliverable
client delivery
Required skills
Clinical safety strategy, pharmacovigilance vendor management, safety assessment and risk management, medical review of ICSRs, data monitoring committee activities, regulatory reporting (IND Annual Reports, DSURs), signal detection and evaluation, clinical case processing, MedDRA and WHO Drug coding
Preferred skills
Designing safety and PV processes, experience with Argus and EDC systems
Technologies
Argus, EDC, MedDRA, WHO Drug
Responsibilities
Serve as clinical safety lead for assigned products; oversee pharmacovigilance vendor activities; manage external service providers and business partners; prepare quarterly Data Monitoring Committee presentations; assist with clinical trial periodic reports; support signal detection and evaluation of trends
Seniority
Director, strategic leadership with hands-on execution
