PV Operation Manager-KunTuo
Core
Manage the collection, processing, and reporting of drug safety information for clinical trials and post-marketing phases in compliance with domestic and international regulations.
Role type
Senior Pharmacovigilance Operations Manager
Builds
Regulatory safety reports (DSUR, PSUR, RMP) and safety databases for life sciences clients
Domain
Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance case processing, regulatory reporting (DSUR/PSUR/RMP), adverse event analysis, medical/pharmacological knowledge, database management, regulatory compliance, training delivery
Preferred skills
Epidemiology, clinical trial protocol review, external vendor management
Technologies
Pharmacovigilance databases, medical literature search tools
Responsibilities
Manage collection of safety information from clinical trials and post-marketing; audit and translate safety reports; submit reports to regulatory authorities; analyze adverse events; support regulatory and ethics committee inquiries; train new employees
Seniority
Senior, hands-on IC
