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Drug Safety Associates

Quanticate

Bengaluru

·

4 w

·

Full time

·

Healthcare

Minimum

₹450000 Per Year

Maximum

₹750000 Per Year

Be part of a mission-driven organization committed to advancing global clinical research while ensuring patient safety at every step.

Position Overview

As a Pharmacovigilance / Drug Safety Associate, you will handle essential drug safety operations, ensuring accuracy, compliance, and timely reporting of safety data for global studies.

Key Responsibilities

Process and review Individual Case Safety Reports (ICSRs)

Ensure compliance with global pharmacovigilance regulations and SOPs

Conduct quality checks and case evaluations

Support signal detection and safety risk management

Maintain safety databases and documentation

Assist with periodic safety reports (PSURs, DSURs, PADERs)

Coordinate with internal teams for timely submissions

Qualifications

Bachelors/Masters in Pharmacy, Life Sciences, Biotechnology, or Nursing

13 years of experience in Pharmacovigilance or Drug Safety

Experience with safety databases (Argus, ArisG, etc.)

Knowledge of global PV guidelines (ICH, EMA, FDA)

Strong communication, attention to detail, and analytical skills.