Senior PV Physician I

Summary

Join PrimeVigilance, a global leader in pharmacovigilance, and contribute to improving patients' lives. Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports, conducting medical/causality assessments, coding, and writing company comments. Support the Qualified Person for Pharmacovigilance in evaluating safety issues. Review articles for ICSRs/SAEs related to medicinal products. Analyze database outputs and complete supporting documentation. We offer training, career development, a supportive environment, and opportunities to work with global colleagues.

Requirements

• Medical qualification as a Physician
• Ability to work effectively cross culturally and value the importance of teamwork
• Presentation skills
• Advanced knowledge of English and MS Office

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, expectedness, and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events
• This includes 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 articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• Reviewing database outputs

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