Medical Reviewer, Aggregate Report Scientist
9 hours ago
**The Company:**
A Clinical Research Organisation (CRO), which supports trials from Phase II to Phase IV and beyond post-launch of products. Services include clinical operations to data services, data analytics and medical writing in compliance with international standards.A growing international team of over 200 colleagues offer support to the pharmaceutical, FMCG and medical device industries.
**Medical Reviewer, Aggregate Report Scientist Role :**
- Review safety assessments, risk/benefits evaluations, Risk Management plans (RMPs) and ad-hoc regulatory reports.
- Perform authoring & medical review of aggregate reports like DSUR, PBRER, SUSAR, PADER, Addendum Reports as well as RMPs of safety deliverables.
- Monitor and manage the quality of documents to meet both internal SOP standards and external regulatory standards.
- Provide inputs and value add from medical perspective at all stages of safety deliverables
- Be completely accountable and responsible for assigned activities like writing, review, coordination, project management and leading the projects.
- Establish & Develop a robust medical review practice across document types within SIRO
**Medical Reviewer, Aggregate Report Scientist Requirements:**
- MBBS / MD
- Minimum 4/5 years relevant experience in working with aggregate reports such as DSURs, SUSARs, PBERERs, RMPs/REMS, SBRs & PADERs
- Conversant with E2F and E2E/E2R and other pharmacovigilance guidelines.
**100% remote**
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