Pharmacovigilance Data Specialist

2 weeks ago

Dindigul, Tamil Nadu, India beBeeDataSafety Full time ₹ 11,63,200 - ₹ 12,90,720

Job Overview

We are seeking experienced professionals to manage generic or client-specific email boxes, register and triage vigilance cases, and coordinate the processing of these cases.

The ideal candidate will have strong organizational and interpersonal skills, with excellent time management skills and the ability to work well within a team.

  • Responsibilities include:
    • Performing local safety case receipt, processing, and data entry, quality control tracking, and ICSR follow-up of all safety information received for clients.
    • Managing email boxes as appropriate.
    • Registering, triaging, assigning, and coordinating the processing of vigilance cases.
    • FOLLOWING UP ON REQUESTS FROM LOCAL REPORTERS.
    • RESPONDING TO QUERIES FROM CLIENTS AND REPORTERS.
    • CARRYING OUT PERIODIC RECONCILIATIONS TO CONFIRM THE PROPER HANDLING OF ALL VIGILANCE REPORTS FOR PLG Clients.

Requirements:

  • Bachelor's or Master's degree in Medicine, Pharmacy, Nursing, or a science-related field, or equivalent experience.
  • 2+ years' experience in pharmacovigilance working for service providers performing data entry and QC of cases.
  • PREVIOUS EXPERIENCE WORKING TO DEADLINES.
  • CLIENT COMMUNICATIONS
  • KNOWLEDGE OF US AND EU PV REGULATIONS.
  • PHARMACEUTICAL BACKGROUND – STRONG UNDERSTANDING OF GVP, GCP, FDA, AND REGULATORY REQUIREMENTS RELATED TO DRUG SAFETY.
  • DEEP KNOWLEDGE OF PHARMACOVIGILANCE PRINCIPLES, ADVERSE EVENT REPORTING, CAUSALITY ASSESSMENT.

Why this role matters: Pharmacovigilance plays a crucial role in ensuring drug safety and preventing adverse events.

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