Senior Pharmacovigilance Officer

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

📋 Description

• Handling 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.

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

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

• Providing mentorship and training to new and junior staff members within the department, including the optimization and development of procedures.

⛳️ Requirements

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

• Proven experience in case processing.

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

• Strong communication and interpersonal skills.

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

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional advancement.

• A friendly and supportive work environment.

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