Pharmacovigilance Associate

Responsibilities

• Process individual case safety reports (ICSRs) in the safety database within regulatory timelines.
• Perform medical coding using MedDRA and assess case seriousness and expectedness.
• Assist in the preparation of periodic safety update reports (PSURs) and risk management plans.
• Support signal detection activities and literature screening for safety information.
• Ensure compliance with local and international pharmacovigilance regulations.

Requirements

• Bachelor's or Master's degree in Life Sciences, Pharmacy, or Nursing.
• 0-2 years of experience in pharmacovigilance or drug safety.
• Knowledge of MedDRA coding and pharmacovigilance databases (e.g., Argus, ArisG).
• Understanding of EU GVP guidelines and ICH E2 series.
• Detail-oriented with excellent documentation skills.