Case Processing Manager, Team Lead (PV Manager)
Ergomed
Ergomed seeks a Case Processing Manager and Team Lead for pharmacovigilance operations in Bucharest. The role involves managing ICSR staff, optimizing team efficiency, processing safety cases, and supporting regulatory affairs activities across multiple functions.
Responsibilities
- Line manage assigned ICSR staff and oversee team performance
- Establish and maintain project-specific KPIs for ICSR activities and process optimization
- Process individual safety cases and conduct second-level quality control reviews
- Manage ICSR deviations and review trackers and timesheet accuracy
- Act as Local Contact Person for Pharmacovigilance and Person Responsible for Local Screening as needed
Requirements
- Life science, pharmacy, nursing, or healthcare-related qualification or pharmacovigilance experience
- 5-6 years pharmacovigilance experience with minimum 3 years in line management
- Excellent written and verbal communication skills
- Strong organizational and attention to detail abilities
- Delegation, planning, and time management skills
- Fluent English and advanced MS Office proficiency
- Technical skills and team collaboration experience
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