- Efficiency in conducting literature searches for authoring various types of reports
- Write and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents, as assigned.
- Perform/review Signal detection activities
- Author/ review RMPs, ad hoc reports, Safety Update reports, Benefit-RiskEvaluation, CCDS supporting document, ACOs, Addendum reports
- Write Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
Graduate/ Postgraduate in Pharma, life sciences or medical sciences
At least 5 years’ experience in the pharmaceutical industry, with at least 3 years of it in medical writing
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