Safety and Pharmacovigilance (PV) Coordinator
Location: Pune, Maharashtra, India
Employment Type: Full-Time
Job Summary
The Safety and Pharmacovigilance (PV) Coordinator is responsible for supporting pharmacovigilance operations, safety data management, regulatory compliance, and safety reporting activities. The role involves coordinating safety-related processes, maintaining accurate documentation, supporting adverse event management, and collaborating with cross-functional teams to ensure compliance with global pharmacovigilance regulations and company procedures.
Key Responsibilities
Pharmacovigilance Operations Support
Support day-to-day pharmacovigilance and drug safety activities.
Assist in the management and tracking of adverse event reports and safety-related documentation.
Ensure accurate and timely processing of safety information in accordance with applicable regulations and internal procedures.
Maintain safety databases, records, and documentation to ensure data integrity and compliance.
Safety Data Management
Review, organize, and maintain safety-related information and documentation.
Assist in data reconciliation, quality checks, and verification of safety data.
Support case processing and safety reporting activities as required.
Ensure completeness, accuracy, and consistency of safety information.
Regulatory Compliance & Documentation
Ensure adherence to global pharmacovigilance regulations, GVP guidelines, and company policies.
Maintain audit-ready documentation and support inspection readiness activities.
Assist with the preparation of reports, metrics, and compliance documentation.
Support implementation of corrective and preventive actions (CAPAs) when required.
Cross-Functional Coordination
Collaborate with internal departments, project teams, sponsors, and external stakeholders.
Coordinate safety-related communications and follow-up activities.
Assist in scheduling meetings, tracking action items, and supporting project deliverables.
Support knowledge sharing and process improvement initiatives.
Quality & Continuous Improvement
Participate in quality review activities and compliance monitoring processes.
Identify process improvement opportunities and support implementation of best practices.
Contribute to maintaining high standards of quality and operational excellence.
Stay current with industry trends, pharmacovigilance regulations, and safety reporting requirements.
Required Qualifications
Education
Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Nursing, Medicine, or a related scientific discipline.
Experience
1–4 years of experience in Pharmacovigilance, Drug Safety, Clinical Research, or Safety Operations.
Experience supporting safety reporting, case processing, or pharmacovigilance activities is preferred.
CRO or pharmaceutical industry experience is an advantage.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Slovakia | Blue Bell | Ireland | McFarland | Minnesota | Regulatory Labeling Manager (NA and LATAM Only) | Zaragoza | Nairobi | Xzagreb | Springville | Bountiful | Medan | Switzerland | Thailand | Remote - Africa | Faridabad | Riga | Victoria | Lousiana | French | Castlebar | Remote - Europe | Hammond | Belgium | Bishop | Texas | Tulsa | Manipal | Lenexa | Perth | Green Way | Melbourne | Hungary | Milwaukee | Leinster | Remote - Middle East | Remote - South America (Latin Americal) |Republic of Colombia :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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