PV Manager Safety Science
Core
Manages the safety profile of new drugs in clinical trials, overseeing case-processing, regulatory reporting, and medical monitoring for a multinational team.
Role type
Senior IC safety science manager (pharmacovigilance)
Builds
Safety data, aggregate safety reports, and regulatory submissions for clinical trial programs
Domain
Life sciences / Clinical research / Pharmacovigilance
Deliverable
client delivery
Required skills
Signal detection, aggregate safety report writing, global regulatory compliance, project management, team leadership, medical-scientific writing, data interpretation
Preferred skills
Therapeutic area knowledge, on-call duty readiness, proposal preparation, staff performance management
Technologies
Safety databases, Microsoft Office products
Responsibilities
Coordinate contracted safety responsibilities including staffing and training; manage the safety team on respective programs; liaise with project leads and clients; fulfill safety scientist activities for signal detection and report writing; oversee maintenance of technology platforms; manage multiple aspects of projects including contractual and regulatory requirements; prepare and present proposals; manage staff including hiring, performance management, and approvals.
Seniority
Senior, hands-on IC with leadership
