Drug Safety Officer

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee local pharmacovigilance operations in alignment with both global and local regulatory standards.

• Assist in the gathering, processing, evaluation, and documentation of adverse events, serious adverse events, and additional safety information.

• Guarantee prompt submission of safety reports and upkeep of local pharmacovigilance records.

• Support inspections, audits, and corrective and preventive action (CAPA) initiatives.

• Partner with internal teams, healthcare providers, regulatory bodies, and external collaborators on safety-related issues.

• Participate in pharmacovigilance training, enhancement of processes, and compliance efforts.

• Aid in safety operations for both marketed products and clinical trials.

• Act as a principal local pharmacovigilance liaison dedicated to a specific global pharmaceutical sponsor.

⛳️ Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related scientific field.

• Relevant experience in Pharmacovigilance, Drug Safety, or Clinical Safety within the pharmaceutical, biotechnology, or CRO sectors.

• Strong understanding of EU GVP guidelines and pharmacovigilance regulations.

• Proficiency in adverse event reporting, safety databases, and pharmacovigilance methodologies.

• Excellent written and verbal communication skills in both English and Polish.

• Outstanding organizational abilities.

• Capability to work autonomously and handle multiple priorities efficiently.

🏝️ Benefits

• Opportunities for both personal and professional development.

• A collaborative, quality-driven, and fulfilling work atmosphere.

• Applicable benefits aligned with local market conditions.