PV System Specialist
Location: Mumbai, Maharashtra, India
Function: Research & Development – Pharmacovigilance (PV) Systems
Employment Type: Full-Time
Company Overview
Abbott Laboratories is a global healthcare leader committed to maintaining the highest standards of pharmacovigilance and regulatory compliance. Within its Established Pharmaceuticals Division (EPD), robust PV systems and governance frameworks ensure adherence to global Good Pharmacovigilance Practices (GVP).
Role Overview
The PV System Specialist is responsible for ensuring compliant implementation and oversight of global pharmacovigilance (PV) systems, training programs, and documentation processes. The role focuses on maintaining PV training matrices, managing electronic systems such as ISOtrain and eDMS, supporting the Pharmacovigilance System Master File (PSMF), and ensuring alignment with global regulatory requirements.
This opportunity is ideal for professionals seeking Pharmacovigilance System Specialist jobs in Mumbai within a global pharmaceutical R&D environment.
Key Responsibilities
PV Training Governance & Compliance
Maintain and update PV training matrices for global, regional, and affiliate PV staff.
Ensure compliant roll-out, tracking, and reporting of PV training via ISOtrain Learning Management System.
Communicate PV training requirements to both PV and non-PV employees across regions.
Assign training modules and retrieve training records within approved systems.
PV Systems & Documentation Management
Establish and maintain GPV (Global Pharmacovigilance) procedures within the electronic Document Management System (eDMS).
Act as Business Administrator for eDMS and provide backup Site System Administrator support.
Support users in resolving eDMS-related issues via vendor-supported OMS processes.
Oversee controlled forms and ensure periodic document review processes are maintained.
Assist with authoring, editing, reviewing, approving, importing, and exporting PV documents.
Maintain oversight of GPV documentation and archive locations.
Act as administrator and coordinator for GPV SharePoint platforms.
Regulatory & Inspection Readiness
Support maintenance of the Pharmacovigilance System Master File (PSMF) in alignment with Good Pharmacovigilance Practice (GVP) Module II.
Participate in internal audits, third-party audits, and health authority inspections.
Track and report PV system Key Performance Indicators (KPIs) to PV Compliance functions.
Review procedural changes across interfacing departments and coordinate GPV responses.
Cross-Functional Collaboration & Project Support
Liaise independently with Clinical, Medical Affairs, Regulatory Affairs, and other cross-functional teams to ensure PV compliance.
Participate in GPV project teams to ensure global regulatory alignment.
Contribute to L&D-wide training initiatives to harmonize training processes.
Represent PV in the EPD Training Community.
Educational Qualifications
Bachelor’s Degree in Pharmacy, Life Sciences, Medicine, Biotechnology, or related scientific discipline.
Experience Required
Minimum 4–7 years of experience in Pharmacovigilance systems, PV compliance, or regulatory operations within the pharmaceutical industry.
Hands-on experience with Learning Management Systems (LMS) such as ISOtrain and electronic Document Management Systems (eDMS).
Strong understanding of Good Pharmacovigilance Practices (GVP) and PSMF maintenance requirements.
Experience supporting audits and health authority inspections preferred.
Core Competencies
Strong knowledge of pharmacovigilance systems and global PV regulations.
Expertise in document lifecycle management and compliance oversight.
High attention to detail and data accuracy.
Excellent coordination and stakeholder management skills.
Ability to manage multiple system-based responsibilities simultaneously.
Strong analytical and problem-solving capabilities.
Why Join Abbott?
Opportunity to strengthen global PV compliance systems within a leading pharmaceutical organization.
Exposure to international pharmacovigilance frameworks and regulatory audits.
Career growth within R&D, PV systems governance, and compliance leadership.
SEO & GEO Keywords: PV System Specialist Mumbai, Pharmacovigilance Systems Jobs India, PV Compliance Careers Mumbai, ISOtrain eDMS Pharmacovigilance Jobs, PSMF Management Jobs India, Abbott PV Regulatory Systems Jobs.
This position is suited for pharmacovigilance system professionals seeking PV System Specialist roles in Mumbai with expertise in training governance, document management systems, PSMF maintenance, and global PV compliance frameworks.
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