Responsibilities
Case Management & Review
- Collect and assess reports of adverse events from healthcare providers, patients, and healthcare systems.
- Perform medical review of safety reports, analyzing patient history, dosage, and the timing of adverse events.
- Query and conduct further assessments when necessary to clarify the nature of adverse reactions.
- Ensure quality control (QC) for post-marketing cases.
Documentation & Compliance
- Create and maintain detailed case reports, ensuring accurate documentation in pharmacovigilance databases (Argus, SafetyEasy).
- Submit safety reports to regulatory agencies such as the FDA, EMA, and relevant national authorities.
- Ensure compliance with Good Pharmacovigilance Practices (GVP) and local regulatory requirements.
Regulatory & Client Communication
- Act as the Local Safety Officer (LSO) on behalf of PLG clients in Poland, including acting as the Local Pharmacovigilance Person (LPPV) nominated to the authorities.
- Conduct local regulatory intelligence screening, tracking updates from health authorities.
- Support and contribute to local pharmacovigilance (PV) activities performed by the Pharmacovigilance / Medical Information teams.
Audits & Inspections
- Participate in audits, inspections, and contribute to action plans to maintain compliance with regulatory and company standards.