Senior Executive - Pharmacovigilance
OR
Last updated on 08 Dec 2025
Overview
The Senior Executive - Pharmacovigilance plays a pivotal role in ensuring the safety and efficacy of pharmaceutical products by monitoring and evaluating their risk-benefit profiles. This position involves collecting, assessing, and reporting adverse events to regulatory authorities, while maintaining compliance with global pharmacovigilance guidelines. The role demands a deep understanding of drug safety, clinical trials, and regulatory requirements. The individual must work collaboratively across departments to ensure product safety and provide insights for risk management strategies. The role contributes to the overall quality and safety assurance of pharmaceutical products.
Job Description
- Oversee and manage pharmacovigilance activities, including the collection, assessment, and reporting of adverse drug reactions (ADRs).
- Ensure timely and accurate submission of safety reports to regulatory agencies in compliance with international standards.
- Conduct risk assessments and signal detection to evaluate the safety profile of pharmaceutical products.
- Collaborate with cross-functional teams such as clinical research, regulatory affairs, and medical affairs to address safety concerns.
- Prepare and review safety-related documents, including clinical safety summaries, periodic safety update reports (PSURs), and risk management plans (RMPs).
- Provide training and guidance to junior staff on pharmacovigilance processes and regulatory requirements.
- Stay updated with global pharmacovigilance regulations and industry trends to ensure compliance and continuous improvement in safety monitoring practices.
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