Global Head of Clinical Safety
Core
Provide medical safety expertise for benefit/risk assessment of products in clinical development, focusing on signal detection, risk management, and managing PV relationships.
Role type
Senior IC clinical safety leader (global)
Builds
Safety strategies, risk management plans, and aggregate safety reports for clinical development
Domain
Biopharmaceuticals / Dermatology
Required skills
Medical safety expertise, signal detection, risk management, aggregate safety reporting, line management, regulatory interactions, clinical trial safety review
Preferred skills
Additional degree in clinical pharmacology/pharmacovigilance/epidemiology
Technologies
DSUR, PSUR, PBRER, RMP, CCDS
Responsibilities
Propose and recommend measures to minimize risks during clinical development; Partner with stakeholders to monitor safety profiles and propose risk management measures; Take ownership of aggregate safety reports and Risk Management Plans; Provide input into safety modules for dossier submission; Contribute to investigator/KOL and IDMC meetings; Lead ongoing safety data review during clinical trials; Line manage a team of up to 5 direct reports.
Seniority
Senior, hands-on IC with line management