PV Physician II
About The Position
For the Client (may include but is not limited to the following): 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
Requirements
- The PV Physician should be medically qualified as a physician.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
