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.

Experience: