Pharmacovigilance

Role & Responsibilities

• Review and evaluate adverse event reports (AERs) for regulatory reportability
• Enter and maintain adverse event data in safety databases
• Perform narrative writing and case documentation
• Communicate with healthcare professionals to obtain follow-up safety information
• Assist in preparation and submission of regulatory safety reports
• Monitor safety literature related to company products
• Collaborate with clinical research, regulatory affairs and PV teams
• Support development and implementation of pharmacovigilance SOPs
• Review safety profiles of new and existing products
• Participate in risk management plan development and execution
• Communicate with regulatory authorities and stakeholders on safety matters

Qualification

• B.Pharm / M.Pharm / Pharm.D / Life Sciences (preferred)

Experience

• Fresher / Entry-level candidates can apply

Skills

• Knowledge of pharmacovigilance and ICSR processing
• Narrative writing skills
• Basic understanding of regulatory safety reporting
• Good communication and documentation skills
• Attention to detail and analytical ability

About the Company

A life sciences organization engaged in pharmacovigilance, clinical research and regulatory safety operations, ensuring patient safety and regulatory compliance across products.