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
Degree in Pharmacy or Life Sciences.
Minimum 3 years of experience in pharmacovigilance (PV), with a focus on post-marketing case processing and QC.
Proven ability to meet deadlines and work efficiently under pressure.
Experience in client communication related to pharmacovigilance matters.
Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP).
Hands-on experience with pharmacovigilance databases (e.g., Argus, SafetyEasy).
Strong attention to detail, organization, and reliability.
Knowledge of local Poland and international regulations.
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Experience handling local case management activities (e.g., translation, data entry, QC, tracking, follow-up requests).
Fluency in Polish; fluency in French is nice to have

Please refer the Job description for details