Full-Time Medical Reviewer I

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:

1. 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.
2. Review literature screening search strategy
3. Review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
4. Reviewing database outputs
5. Review and provide input in Periodic Safety Update Reports
6. Review and provide input in Development Safety Update Reports
7. Participating in signal detection activities including meetings and writing signal detection reports
8. 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, organize, prioritize and execute multiple tasks
• Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
• Communication skills
• Presentation skills

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