Pharmacovigilance Medical & Scientific Writer With Crest - Pune

• Identifying and evaluating individual case safety reports (ICSRs) of adverse drug reactions from the published literature
• creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing ) to support the drug safety reporting and information requirements of pharma industry clients
• Required background and experience: you will have working experience in the pharmacovigilance/drug safety field and a background in medicine or pharmacy
• Ideal experience would include:
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• Scanning the literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
• Detailed evaluation of individual case reports e.g. determining seriousness of adverse events, determination of drug causality, subsuming signs and symptoms into clinical diagnoses etc.
• Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities

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