Pharmacovigilance Executive

We are looking for a dedicated Pharmacovigilance Associate/ Executive with 1–3 years of experience to support safety monitoring activities and ensure compliance with global drug safety regulations.

Key Responsibilities

• Perform case processing, including data entry, coding, assessment, and follow-up of Individual Case Safety Reports (ICSRs).
• Conduct literature screening and support signal detection activities.
• Ensure timely and accurate reporting of adverse events to regulatory authorities.
• Assist in preparation of safety reports such as PSURs/PBRERs and DSURs.
• Maintain and update safety databases as per SOPs and regulatory guidelines.
• Collaborate with cross-functional teams to support pharmacovigilance operations.
• Ensure compliance with global PV regulations, SOPs, and quality standards.
• Compilation of Periodic Safety Report and Risk Management Plan for products
• Compilation of Pharmacovigilance Master File
• Record Keeping of PSUR, RMP and all Pharmacovigilance Documents submitted in respective countries

Required Qualifications & Skills

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
• 1–3 years of experience in pharmacovigilance or drug safety.
• Good understanding of ICH, FDA, EMA, and other PV regulations.
• Proficiency in safety databases (e.g., Argus, ARISg) is an advantage.
• Strong attention to detail, analytical skills, and ability to work under timelines.
• Good written and verbal communication skills.

Job Type: Full-time

Benefits:

• Health insurance
• Paid time off
• Provident Fund

Work Location: In person