Case Processing Manager, Team Lead (PV Manager)
Core
Line manages ICSR staff and oversees contracted pharmacovigilance activities, including case processing, quality control, and process optimization.
Role type
Senior IC Case Processing Manager / Team Lead
Builds
Efficient ICSR operations and safety data processing pipelines
Domain
Life Sciences / Pharmacovigilance
Deliverable
Production ML models | product features | dashboards & analysis | client delivery | physical/clinical work
Required skills
ICSR case processing, 2nd QC, team management, KPI creation, process optimization, deviation management, tracker review, SME support
Preferred skills
RA & PV Network support, LCPPV/PRLS role execution
Technologies
MS Office
Responsibilities
Line manages assigned ICSR staff; Creates and maintains project specific KPIs for contracted ICSR activities; Proposes process changes to ICSR Operational Lead; Manages ICSR deviations with ICSR Operational Lead support; Reviews trackers and timesheet data and ensures accuracy; Is involved in ICSR processing and 2nd QC of cases; Supports other departments as approved and instructed by ICSR Operational Lead; Operates as the assigned team SME and supports other SMEs; Supports the RA & PV Network Department as needed, including acting as the LCPPV and PRLS.
Seniority
Senior, hands-on IC with management responsibilities