Pharmacovigilance Specialist
Core
Establish and maintain the local pharmacovigilance system for marketing authorization holders in Tunisia, performing local PV operations including ICSR management, literature search, and signal detection.
Role type
Senior Pharmacovigilance Operations Lead (Local)
Builds
Local PV systems, procedures, and safety reporting for pharmaceutical clients
Domain
Pharmaceutical industry, Drug Safety, Pharmacovigilance
Required skills
Pharmacovigilance system setup, ICSR management, Literature search, Signal detection, PSUR/RMP adaptation, Risk minimization measures, Audit participation, Medical information review
Preferred skills
Project management, Quality management, PV certification
Technologies
PV systems, Standard Operating Procedures, Working Practices
Responsibilities
Set up and manage the local pharmacovigilance system, Perform local ICSR management and literature search, Adapt and submit PSUR/RMP, Implement risk minimization measures, Participate in PV audits and inspections, Provide monthly PV status reports, Train affiliate employees and third parties
Seniority
Senior, Management capacity