PV Physician II
PV Physician II
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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 postmarketing 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 followup 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
Qualifications :
The PV Physician should be medically qualified as a physician with demonstrated 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
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
