About the job
Core
Managing active monitoring of Pharmacovigilance (PV) and Post-Marketing Surveillance (PMS) activities in compliance with Risk Management Plans (RMP), including managing investigation agencies and CROs, reviewing and approving reports, and updating regulatory documents.
Role type
Pharmacovigilance Specialist (PV/PMS)
Builds
Regulatory compliance reports and documentation for drug safety
Domain
Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance regulations, Risk Management Plan (RMP) management, Investigational Site/CRO management, Regulatory document review (PSMF, PSUR, DSUR), ICSR reporting and reconciliation, SOP maintenance, Drug safety training
Preferred skills
None stated
Technologies
None stated
Responsibilities
Active monitoring of PV/PMS activities per RMP; Managing investigation agencies and CROs; Periodic updates of PV documents (PSMF, RMP, PSUR, DSUR) and regulatory agency response; ICSR reporting to regulatory agencies and reconciliation with partners; Maintaining PV SOPs; Conducting drug safety training for employees
Seniority
Intern (3 months), potential conversion to regular employee