Senior PV Associate
Core
Managing Individual Case Safety Reports (ICSRs) and safety data for pharmaceutical and biotechnology clients.
Role type
Senior Pharmacovigilance Associate (ICSR Management)
Builds
Monthly safety reports and regulatory-compliant safety databases for clients
Domain
Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
ICSR processing, SAE/SUSAR management, MedDRA and WHO coding, data reconciliation, workflow management
Preferred skills
LCPPV (Local Contact Person for Pharmacovigilance) coordination, PRLS (Person Responsible for Local Screening) duties
Technologies
PrimeVigilance platform, MS Office
Responsibilities
Processing ICSRs from all sources in compliance with regulations and client requirements; Performing ICSR follow-up; Managing SAE/SUSARs including unblinding and protocol review; Handling product quality complaints; Generating database outputs and monthly client reports; Acting as LCPPV and PRLS for designated countries/languages
Seniority
Senior, hands-on IC
