PV Associate
Core
Support pharmacovigilance activities including processing Individual Case Safety Reports (ICSRs), managing SAE/SUSARs, and handling product quality complaints within the ICSR management unit.
Role type
Junior Individual Contributor Pharmacovigilance Associate
Builds
Safety data processing and regulatory compliance reports for pharmaceutical clients
Domain
Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
ICSR processing, SAE/SUSAR management, MedDRA and WHO coding, data reconciliation, quality complaint handling
Preferred skills
LCPPV (Local Contact Person for Pharmacovigilance) coordination, PRLS (Person Responsible for Local Screening) duties
Technologies
PrimeVigilance, MS Office
Responsibilities
Process Individual Case Safety Reports (ICSRs) from all sources in compliance with regulations and client requirements; Perform ICSR follow-up; Manage SAE/SUSARs including unblinding and protocol review; Handle product quality complaints and interact with Quality Assurance; Support PV processes related to ICSR management; Act as LCPPV for specified country and PRLS for designated language as needed
