PV Physician II

Summary

Join PrimeVigilance, a global leader in pharmacovigilance, as a Pharmacovigilance (PV) Physician II. You will play a key role in medical reviews of ICSRs and literature, signal detection reporting, and contributing to aggregate reports. This position requires a medical background with demonstrated pharmacovigilance experience. PrimeVigilance offers excellent training, career development, and a supportive work environment with opportunities for global collaboration. The company prioritizes diversity, equity, and inclusion, fostering a human-centric culture. PrimeVigilance values employee well-being and offers a strong emphasis on personal and professional growth.

Requirements

• The PV Physician should be medically qualified as a physician with demonstarted experience in PharmacoVigilance and working in a clinical setting
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
• Communication skills
• Presentation skills

Responsibilities

• To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers
• To support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
• To review and provide input in periodic reports
• To review literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• Reviewing database outputs
• Can be delegated to support signal detection activities upon acquiring sufficient experience
• Proposing a course of action whenever a new risk is identified

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language