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Looking to grow your career in pharmacovigilance (PV)? A leading global healthcare company is hiring a PV Specialist in Mumbai. This role offers hands-on exposure to drug safety, regulatory compliance, and global PV systems, making it ideal for candidates with a pharmacy or life sciences background.
If you have experience in case processing, safety reporting, or PV compliance, this opportunity can accelerate your career in drug safety and risk management.
Key Responsibilities โ PV Specialist
As a Pharmacovigilance Specialist, you will support affiliate-level PV operations and ensure compliance with local and global regulations:
- Maintain Pharmacovigilance (PV) Quality Management Systems
- Handle adverse event (AE) reporting, receipt, and reconciliation of safety data
- Perform safety surveillance including literature and regulatory website screening
- Prepare Periodic Safety Update Reports (PSURs) and Risk Management Plans
- Manage regulatory submissions for safety information
- Conduct PV training for internal teams
- Ensure PV compliance across India, Nepal, Bhutan, Sri Lanka, and Maldives
- Support PV audits, inspections, and compliance metrics
- Maintain Pharmacovigilance System Sub File (PSSF)
- Review market research studies, PSPs, and digital assets from a PV perspective
- Coordinate with health authorities and internal stakeholders
Required Qualifications
- Bachelorโs degree in Pharmacy, Life Sciences, or related field
- Experience in pharmacovigilance or drug safety preferred
- Strong understanding of local PV regulations
- Good knowledge of ICSR processing, safety databases, and compliance frameworks
- Proficiency in MS Office tools
- Excellent communication and stakeholder management skills
- High attention to detail and regulatory accuracy
Preferred Skills (Good to Have)
- Experience with global PV systems
- Exposure to medical devices and food supplement vigilance
- Knowledge of PV agreements and due diligence processes
Salary & Benefits
- Estimated Salary: โน4.5 LPA โ โน8 LPA (based on experience)
- Opportunity to work with a global healthcare leader
- Exposure to multi-country pharmacovigilance operations
- Strong career growth in drug safety & regulatory affairs
- Collaborative and compliance-driven work environment
Job Details
- Job Title: PV Specialist
- Location: Mumbai, India
- Job Type: Full-Time
- Department: Medical & Scientific Affairs
- Division: Established Pharmaceuticals
How to Apply
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