Medical Reviewer II
Medical Reviewer II
Posted on :
20-12-2024
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1 Vacancy
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Job Description
Job Description
The Medical Reviewer II is responsible for medical review of lCSRs and literature review writing signal detection reports supporting writing and or reviewing of aggregate reports (DSURS PSURS/PBRERs/PADERS) as required by the Company or Client.
For the Client:
- To review and approve postmarketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding seriousness assessment Company causality and comment listedness/expectedness and followup questions.
- To act as a Qualified Person for Pharmacovigilance or 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 Safety Update Reports Development Safety Update Reports 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
- To cooperate in the preparation of and provide input in Risk Management Plans
- Supporting the preparation of responses to regulatory authority requests
- Signalling
- Reviewing line listings
- Participating in signal detection activities including meetings writing signal detection reports if applicable if required and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
- Evaluating and categorizing possible signals and proposing a course of action
- Supporting preparation and review of benefitrisk reports
Qualifications :
- The PV Physician should be medically qualified as a physician
- Previous experience in pharmacovigilance
- Ability to review different aggregate report types including PBRERs and DSURs
- Expertise in signal detection activities is essential
- Excellent interpersonal skills
- Ability to plan organise prioritise and execute multiple tasks
- Ability to work effectively crossculturally and crossfunctionally and value the importance of teamwork
- Communication skills
- Presentation skills
- English advanced (spoken written)
- Advanced literacy (MS Office)
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
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