Pharmacovigilance Associate (Novotech)

Roles and Responsibilities

Job Title: Pharmacovigilance Associate

Job Identification: 3832

Job Type: Full-Time

Location:

Ground Floor, Unit 1, Block E, Helios Business Park,
Bangalore – 560103

The Pharmacovigilance Associate is responsible for monitoring and managing the safety aspects of clinical studies and post-marketing surveillance activities. This includes overseeing the safety mailbox, preparing safety management plans, and setting up safety databases for clinical studies. The role ensures that all safety-related data is accurately collected, documented, and maintained throughout the study lifecycle.

Additionally, the associate is responsible for processing and submitting Individual Case Safety Reports (ICSRs), including SAEs, SUSARs, and AEs, in compliance with International Council for Harmonisation Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and applicable regulatory requirements. The role requires strong attention to detail and a commitment to maintaining compliance with global safety regulations to ensure patient safety and regulatory readiness.