B&S Group is hiring a Medical Information & Pharmacovigilance Associate for its pharmaceutical operations in Vadodara. This opportunity is suitable for pharmacy professionals with 2–6 years of experience in pharmacovigilance, medical information, safety operations, case reconciliation, and regulatory compliance.
The selected candidate will support Medical Information services while contributing to critical pharmacovigilance activities, including PV mailbox management, adverse event identification, product complaint handling, case reconciliation, KPI reporting, and XEVMPD data maintenance.
Candidates with a B.Pharm degree and experience in Pharmacovigilance and Medical Information are encouraged to apply.
Key Responsibilities
PV Mailbox Management
The Medical Information & Pharmacovigilance Associate will:
- Monitor and triage the functional Pharmacovigilance (PV) mailbox daily.
- Screen incoming communications for potential Adverse Events (AEs).
- Identify Product Complaints (PCs) and Medical Information inquiries.
- Acknowledge and log incoming safety information.
- Route safety cases to appropriate internal teams and business partners within required timelines.
- Ensure compliance with internal SOPs and pharmacovigilance procedures.
Medical Information Activities
Key Medical Information responsibilities include:
- Handle medical inquiries received through telephone and email.
- Respond to inquiries from healthcare professionals, patients, and regulatory authorities.
- Provide accurate, balanced, evidence-based, and scientifically appropriate responses.
- Use approved company documents and medical information resources.
- Maintain complete documentation of medical inquiries and responses.
- Escalate complex or unaddressed medical queries to the appropriate manager.
Pharmacovigilance Case Reconciliation
The selected candidate will support regular safety data reconciliation activities, including:
- Reconciliation of Adverse Events and Individual Case Safety Reports (ICSRs).
- Compare safety information across relevant departments and systems.
- Coordinate with Medical Information, Legal, Quality Assurance, Product Complaint teams, and Business Partners.
- Identify missing cases and data discrepancies.
- Monitor potential timeline breaches.
- Resolve reconciliation discrepancies according to applicable procedures.
- Maintain reconciliation documentation and reports for audits and inspections.
- Support compliance with Safety Data Exchange Agreement (SDEA) requirements.
Monthly KPI Reporting
Responsibilities will also include:
- Support the preparation of monthly Pharmacovigilance KPI reports.
- Collect and compile departmental performance data.
- Review metrics for accuracy and completeness.
- Track operational and compliance performance indicators.
- Support timely reporting for management review and quality monitoring.
XEVMPD and Regulatory Data Management
The Medical Information & Pharmacovigilance Associate will support regulatory data management activities, including:
- Prepare and validate XEVMPD data.
- Support XEVMPD submissions according to applicable EMA requirements.
- Maintain accurate product information throughout the product lifecycle.
- Update regulatory data for new Marketing Authorisations.
- Support updates related to variations, renewals, and transfers.
- Perform quality checks between regulatory documentation and XEVMPD records.
- Investigate and resolve XEVMPD validation errors.
- Maintain submission records and acknowledgements.
- Coordinate with Regulatory Affairs teams regarding product changes affecting XEVMPD submissions.
Qualifications
Educational Qualification
- B.Pharm (Bachelor of Pharmacy)
Candidates with relevant pharmaceutical and life sciences experience may be preferred based on job requirements.
Experience Required
- 2–6 years of relevant experience
Applicants should have exposure to one or more of the following areas:
- Pharmacovigilance
- Medical Information
- Drug Safety
- PV Operations
- Adverse Event Processing
- Safety Case Reconciliation
- Product Complaint Management
- Regulatory Compliance
- XEVMPD
- Pharmaceutical Regulatory Systems
Required Skills
Candidates applying for this Medical Information and Pharmacovigilance job in Vadodara should have knowledge of:
- Pharmacovigilance processes
- Medical Information services
- Adverse Event identification
- Product Complaint handling
- PV mailbox management
- Safety data reconciliation
- ICSR processes
- Regulatory compliance
- UK and EU pharmaceutical regulations
- XEVMPD requirements
- Standard Operating Procedures (SOPs)
- KPI reporting
- Quality and compliance standards
- Scientific and medical communication
- Documentation and record management
Why Consider This Pharmacovigilance Job?
This role offers an opportunity to gain experience across multiple pharmaceutical functions, including Medical Information, Pharmacovigilance, Regulatory Operations, and Quality Compliance.
Professionals in this position can develop practical exposure to:
- End-to-end Medical Information operations.
- PV mailbox and safety communication management.
- Adverse Event and Product Complaint identification.
- Cross-functional safety case reconciliation.
- Pharmacovigilance compliance metrics and KPI reporting.
- European regulatory data requirements.
- XEVMPD product data management.
- Regulatory Affairs collaboration.
The role may be particularly valuable for pharmacy professionals looking to build or strengthen a career in Pharmacovigilance, Drug Safety, Medical Information, or Regulatory Affairs.
₹4.5 LPA – ₹8 LPA
Benefits may include:
- Full-time permanent employment.
- Experience in Pharmacovigilance and Medical Information.
- Exposure to UK and EU regulatory requirements.
- Experience with XEVMPD regulatory systems.
- Cross-functional collaboration with Medical, Quality, Legal, and Regulatory Affairs teams.
- Professional growth in pharmaceutical safety and regulatory operations.
How to Apply
