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This job expired on 11/09/2026. It no longer accepts applications.
Pharmacovigilance Specialist (Hybrid)
Cognizant · Mumbai et périphérie
Job description
About the role
We are looking for a Pharmacovigilance Specialist to join our research and development team in a hybrid work model. You will support the safe and effective use of medicinal products by conducting data‑driven safety evaluations and collaborating across functions to improve patient safety and regulatory compliance.
Key responsibilities
- Perform end‑to‑end case handling activities, ensuring timely safety reporting to regulatory authorities.
- Review clinical and post‑marketing safety information to identify signals and contribute to risk assessments.
- Analyze safety data using company systems, detect trends, and escalate findings to medical safety experts.
- Document case handling steps with clear narratives for audits and inspections.
- Collaborate with R&D teams to integrate safety insights into study design and product lifecycle decisions.
- Coordinate with quality and compliance teams to follow pharmacovigilance procedures and improve SOPs.
- Support preparation of safety sections for regulatory submissions and periodic reports.
- Engage with technology teams to refine pharmacovigilance tools for efficient data capture.
- Participate in internal audits and readiness activities, providing required documentation.
Required profile
- Degree in life sciences, pharmacy, medicine or a related discipline.
- 2–4 years of experience in pharma R&D with direct exposure to pharmacovigilance practices.
- Working knowledge of safety data review tools or databases.
- Ability to manage workload within day‑shift expectations without travel.
Required skills
- Familiarity with pharmacovigilance case processing and regulatory reporting.
- Experience using safety data review systems.
- Strong analytical skills for trend detection and risk assessment.
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Cognizant
Mumbai et périphérie
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