Looking for the latest Pharmacovigilance jobs in India? Exemed is inviting applications for the position of Pharmacovigilance QA Officer at its Vadodara office. This opportunity is ideal for B.Pharm and M.Pharm professionals with experience in Pharmacovigilance Quality Assurance, regulatory compliance, audit management, and safety reporting.
Candidates with knowledge of GVP guidelines, ICH regulations, PV audits, PSMF management, and quality systems can apply for this exciting Pharmacovigilance QA Officer job in Vadodara.
Job Overview
| Particulars | Details |
|---|---|
| Position | Pharmacovigilance QA Officer |
| Company | Exemed |
| Location | Vadodara, Gujarat |
| Experience | 0–5 Years |
| Qualification | B.Pharm, M.Pharm |
| Employment Type | Full-Time |
| Department | Quality Assurance |
| Industry | Pharmaceutical & Life Sciences |
Key Responsibilities
The selected Pharmacovigilance QA Officer will be responsible for:
- Ensuring compliance of the Pharmacovigilance system with GVP, ICH, and local regulatory requirements.
- Supporting internal audits, partner audits, and regulatory inspections.
- Maintaining and updating local and global Pharmacovigilance System Master Files (PSMF).
- Reviewing and managing Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs).
- Conducting quality reviews of Individual Case Safety Reports (ICSRs), aggregate reports, and PV documentation.
- Maintaining safety databases and compliance trackers.
- Managing Medical Information (MI) and Product Quality Complaints (PQCs).
- Developing and updating Pharmacovigilance SOPs, work instructions, and quality documents.
- Tracking deviations, CAPAs, and change control activities.
- Monitoring CRO and vendor Pharmacovigilance activities.
- Supporting signal detection and safety data evaluation activities.
- Delivering Pharmacovigilance training programs and compliance awareness sessions.
Required Qualifications
Educational Qualification
- B.Pharm
- M.Pharm
Preferred Skills
- Pharmacovigilance
- Quality Assurance
- GVP Compliance
- ICH Guidelines
- PSMF Management
- Audit & Inspection Readiness
- ICSR Review
- Signal Detection
- CAPA Management
- SOP Development
- Regulatory Compliance
- Medical Information Handling
- Product Quality Complaint Management
Why Join Exemed?
- Opportunity to work in a growing Pharmacovigilance environment.
- Exposure to global regulatory requirements and compliance systems.
- Hands-on experience in audits, inspections, and quality management.
- Career growth in Pharmacovigilance Quality Assurance.
- Collaborative pharmaceutical industry work culture.
How to Apply
Interested candidates can share their resume on recruitment@exemedpharma.com