Role & responsibilities

• Perform case processing and safety data entry for Individual Case Safety Reports (ICSRs).
• Review and assess adverse event reports received from clinical trials, spontaneous sources, literature, and other channels.
• Perform data entry, medical coding, narrative writing, and case follow-up as per standard procedures.
• Conduct seriousness, expectedness, and causality assessments based on applicable guidelines and company procedures.
• Perform MedDRA coding for adverse events and WHO Drug coding for medicinal products.
• Ensure accurate and timely processing of safety cases within defined timelines.
• Support quality checks and reconciliation of safety data.
• Maintain proper documentation and compliance with pharmacovigilance SOPs and regulatory requirements.
• Assist with safety databases such as Argus Safety and other PV systems.
• Support preparation of safety reports and other pharmacovigilance-related documentation.

Preferred candidate profile

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Microbiology, Nursing, Medicine, or a related healthcare discipline.
• Freshers and candidates with relevant pharmacovigilance experience may apply.
• Basic understanding of Pharmacovigilance, Drug Safety, ICSR, Adverse Events, and Clinical Research.
• Knowledge of MedDRA coding, WHO Drug coding, and safety case processing is preferred.
• Familiarity with Argus Safety or other pharmacovigilance databases is an advantage.
• Good written and verbal communication skills.
• Strong attention to detail and analytical skills.
• Ability to understand medical terminology and review clinical information accurately.
• Willingness to work within defined regulatory timelines and quality standards.
• Good working knowledge of MS Office, particularly Word and Excel.

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