Medical Reviewer II
Medical Reviewer II
Posted on :
20-12-2024
Employer Active
1 Vacancy
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Job Description
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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