The role supports the Drug Safety Unit in managing pharmacovigilance activities for IBSA products during both post-marketing and clinical development phases
Job Summary
The role supports the Drug Safety Unit in managing pharmacovigilance activities for IBSA products during both post-marketing and clinical development phases.
Key responsibilities include collecting, registering, and managing adverse event cases from various sources while ensuring compliance with international regulations.
The specialist will prepare critical safety reports such as Periodic Benefit-Risk Evaluation Reports (PBRER) and Development Safety Update Reports (DSUR).
Matching Summary
The role supports the Drug Safety Unit in managing pharmacovigilance activities for IBSA products during both post-marketing and clinical development phases.
Skills & Requirements
Must-have
Post-marketing pharmacovigilance experience
Clinical trial safety monitoring
ICSR data collection and management
ICH EMA Swissmedic regulatory knowledge
PBRER and DSUR report preparation
Nice-to-have
Training delivery to internal departments
Experience with PVA agreements
Strong English communication skills
SOP and working instruction maintenance
Key Requirements
Degree in scientific disciplines (Pharmacy, Biology, etc.)
Minimum 2 years of pharmacovigilance experience
Proficiency in English written and spoken
Knowledge of ICH, EMA, UK, and Swissmedic guidelines