Opening for Pharmacovigilance Expert @ Crest - Pune
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Job Description:
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:
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 authoritie
Salary: 2,50,000 - 5,50,000 P.A
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:R&D
Role:Chemical Research Associate/Scientist
Click here to apply
Apply
Job Description:
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:
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 authoritie
Salary: 2,50,000 - 5,50,000 P.A
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:R&D
Role:Chemical Research Associate/Scientist
Click here to apply
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