Pharmacovigilance Physician II
Location
Bangalore | India
Job description
The Pharmacovigilance (PV) Physician II is responsible for medical review of ICSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS, PBRERs, PADERS).
- 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
- 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
Job tags
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