Medical Reviewer I
Medical Reviewer I
Posted on :
20-12-2024
Employer Active
1 Vacancy
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Job Description
The Medical Reviewer I is responsible for medical review of lCSRs and literature review writing of signal detection reports supporting writing and or reviewing of aggregate reports (DSURS PSURS/PBRERs/PADERS) as required by the Company or Client.
Responsibilities include:
- 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 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
- To review and provide input in Periodic Safety Update Reports
- To review and provide input in Development Safety Update Reports
- Participating in signal detection activities including meetings and writing signal detection reports
- Proposing a course of action whenever a possible signal is identified
Qualifications :
- Medically qualified as a physician with demonstrated experience in Pharmacovigilance
- Any experience in aggregate reports and signal detection is desirable
- 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
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