Senior PV Associate / Junior PV Officer

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

📋 Description

• Management of Individual Case Safety Reports from various sources (post-marketing and clinical trials, including device and combination products) in adherence to relevant regulations, PrimeVigilance procedures, and client-specific requirements and timelines.

• As a vital team member, there is an expectation to efficiently cover all phases of a workflow cycle, excluding Medical Review.

• Independent management of SAE/SUSAR (submissions, unblinding, clinical trial reconciliations).

• Compilation of database outputs for routine reporting (PBRER, DSUR, PADER, etc.).

• Mentoring and guiding new and junior staff within the department, including optimization and development of procedures.

⛳️ Requirements

• Background in life sciences or biomedical fields – a healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and proven experience in Pharmacovigilance case processing.

• Proven experience in case processing.

• Preferred experience with ARGUS.

• Skills in time and issue management, delegation, organization, and multitasking, with a strong attention to detail.

• Excellent interpersonal and communication abilities.

• Proficient in English, both spoken and written, at a minimum of C1 level.

🏝️ Benefits

• Opportunities for internal training and career advancement.

• A strong focus on personal and professional development.

• A friendly and supportive workplace culture.

• The chance to collaborate with colleagues from around the globe, with English as the primary language of communication.