A leading opportunity is open for a PV Specialist in Mumbai with Abbott (EPD Established Pharma division). This role supports pharmacovigilance (PV) operations, acting as an Affiliate Safety Representative (ASR) backup across India and neighboring regions including Nepal, Bhutan, Maldives, and Sri Lanka.
This pharmacovigilance PV Specialist job in Mumbai is critical for ensuring drug safety compliance, regulatory reporting, and maintenance of the Affiliate PV system in alignment with global and local guidelines.
Key Responsibilities โ PV Specialist Mumbai
The PV Specialist (ASR Backup) will be responsible for:
- Maintaining Affiliate PV System Country Chapter and SOPs
- Receipt, documentation, and reconciliation of safety data
- Literature and health authority screening for safety surveillance
- Preparation of periodic safety reports and Risk Management Plans
- Regulatory submission of safety information across India & neighboring regions
- PV training for internal EPD staff
- PV compliance tracking and audit/inspection coordination
- Management of PV agreements and service contracts
- Support for clinical studies and non-interventional programs
- Review of prescribing information and market research studies (PV perspective)
- Ensuring PV compliance for drugs, devices, and supplements
- Maintenance of Pharmacovigilance System Master File (PSSF)
This PV Specialist pharmacovigilance role in Mumbai Abbott India ensures regulatory compliance and patient safety excellence.
Eligibility Criteria / Qualifications
To apply for this PV Specialist job in Mumbai, candidates should have:
- Degree in Pharmacy / Life Sciences or equivalent
- Prior pharmacovigilance experience (preferred but not mandatory)
- Strong understanding of PV regulations (India & global)
- Excellent attention to detail and documentation skills
- Proficiency in MS Office and computer systems
- Strong English communication skills
- Ability to coordinate with cross-functional stakeholders
Preferred Skills
- PV case processing and safety database knowledge
- Regulatory compliance understanding (ICH-GVP guidelines)
- Experience in pharma/EPD or CRO environment
- Training, audit, or quality management exposure
Benefits โ Abbott PV Specialist Role
Working with Abbott offers:
- Global healthcare exposure across multiple regions
- Structured pharmacovigilance career growth
- Work in a regulated, high-impact safety environment
- Cross-functional collaboration with global PV teams
- Strong learning & compliance-driven culture
How to Apply
