Pharmacovigilance Specialist
About the Role
Roles & Responsibilities
• Manage Safety Data Exchange Agreements (SDEA) lifecycle
• Prepare and maintain Pharmacovigilance System Master Files (PSMF)
• Ensure compliance with PV Quality Management Systems
• Coordinate with global safety teams
• Act as Single Point of Contact (SPOC) for regional PV activities
• Liaise with regulatory authorities and maintain inspection readiness
• Support PV audits and inspections
• Track and update safety documentation
• Ensure compliance with local and global regulations
• Support risk management activities and review PV processes for quality improvements
• Collaborate with cross-functional stakeholders
• Provide regulatory input for PV submissions
• Maintain accurate PV records and logs
Qualification
• B.Pharm or M.Pharm in Pharmacy, Pharmacology, Life Sciences, or related discipline
Experience
• 5-10 years of experience in Pharmacovigilance
Vacancies
• 1 Vacancy
Skills
• SDEA management
• PSMF preparation and maintenance
• PV Quality Management Systems
• Global pharmacovigilance regulations
• ROW regulatory knowledge
• Signal detection awareness
• Risk management planning
• Audit readiness
• Documentation compliance
• Stakeholder coordination
About The Company
Dr. Reddy's Laboratories is a global pharmaceutical company committed to providing affordable and innovative medicines. Through its research, development, manufacturing, and commercialization, Dr. Reddy’s aims to make high-quality healthcare accessible across international markets.
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