Medical Information & Pharmacovigilance Associate

Job Summary

The Medical Information & Pharmacovigilance Associate is responsible for delivering a high-quality Medical Information service by handling enquiries received via telephone and email, providing accurate, balanced and evidence-based responses, and maintaining complete documentation. The role also supports pharmacovigilance activities through identification and forwarding of adverse events and product quality complaints, management of the Pharmacovigilance mailbox, reconciliation activities, maintenance of product information within regulatory systems including XEVMPD, and preparation of departmental compliance metrics. The role requires adherence to company SOPs, UK and EU regulatory requirements, and applicable quality standards.

Key Responsibilities

1. PV Mailbox Handling

• Monitor and triage the functional safety/PV mailbox on daily basis.
• Screen incoming emails for potential Adverse Events (AEs), Product Complaints (PCs), and Medical Information inquiries.
• Acknowledge, log, and route incoming safety information to appropriate internal teams or partners within strict timelines.

2. Medical Information

• Handle and document medical inquiries from healthcare professionals, patients, and regulatory authorities regarding company products.
• Provide accurate, balanced, and scientifically rigorous responses using approved internal documents.
• Escalate complex or unaddressed medical queries to the manager.

3. Case Reconciliation

• Perform regular reconciliation of safety data (AEs/ICSRs) between the safety database and other departments (e.g., Medical Information, Legal, Quality Assurance/Product Complaints, or Business Partners).
• Identify discrepancies, missing cases, or timeline breaches as per SDEA obligations.
• Document reconciliation findings, resolve discrepancies, and archive reconciliation reports for audits and inspections.

4. Generate monthly KPI reports

• Support the preparation and generation of monthly Pharmacovigilance department KPI reports by collecting, compiling, and reviewing relevant performance data.
• Assist in tracking departmental metrics and ensuring accurate and timely reporting for management review and quality monitoring.

5. Regulatory Systems (XEVMPD)

• Prepare, validate and submit XEVMPD data in accordance with EMA requirements.
• Maintain the accuracy of product data within the XEVMPD database throughout the product lifecycle.
• Support updates arising from new Marketing Authorisations, variations, renewals and transfers.
• Perform quality checks to ensure consistency between regulatory documentation and XEVMPD records.
• Investigate and resolve XEVMPD validation errors.
• Maintain records of submissions and acknowledgements.
• Liaise with Regulatory Affairs regarding changes affecting XEVMPD submissions.