Senior PV Associate / Junior PV Officer

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

📋 Description

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

• As a vital team member, you are expected to proficiently handle all aspects of the workflow cycle, excluding Medical Review.

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

• Generating database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).

• Mentoring and coaching new and junior staff within the department, including optimizing and developing procedures.

⛳️ Requirements

• 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.

• Experience with ARGUS is preferred.

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

• Strong interpersonal and communication abilities.

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

🏝️ Benefits

• A strong focus on personal and professional development.

• A friendly and supportive working atmosphere.

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

• Opportunities for internal training and career advancement.