Pharmacovigilance Expert

Job Description

A Pharmacovigilance (pv) Expert ensures that pharmaceutical drugs are safe for patients by monitoring, identifying, and preventing adverse side effects throughout the entire lifecycle of a medication. They play a vital role in protecting public health and regulatory compliance.The core duties and responsibilities are broken down into three main categories:1. Case Management and Reporting
• Processing Reports: Collecting, reviewing, and tracking individual case safety reports (icsrs) from healthcare professionals and patients.
• Minimum Criteria Verification: Ensuring that every report includes the 4 minimum validity criteria: an identifiable patient, an identifiable reporter, a suspect drug, and an adverse event.
• Signal Detection: Analyzing safety data and databases to spot early warning signs or patterns of previously unrecognized drug hazards.
• Aggregate Reporting: Drafting and reviewing periodic safety reports, such as Periodic Benefit risk evaluation reports (pbrers) and Developmental Safety Update Reports (dsurs)
• Clinical Trial Support: Contributing to clinical trial protocols by ensuring safety risks are evaluated and Reference Safety Information (rsi) is accurate.
3. Risk Management and Compliance
• Risk Management Plans (rmps): Developing strategies to mitigate and communicate the risks associated with both investigational and marketed drugs.
• Regulatory Inspection Readiness: Conducting internal pv audits and ensuring the company adheres to strict global legislative standards.
• Label Updates: Collaborating with medical and marketing teams to update Patient Information Leaflets (pils) and Summary of Product Characteristics (smpcs) as new safety profiles emerge.

Keyskills :
pharmacovigilancepharma marketingpharmapharmacology