Established in 2006, Crest is an IT and ITES company that offers services in premedia, data conversion, software development, research & analysis and marketing & BPO. We are a Springer group company with invaluable insight into European and American markets and the advantage of being based in India. We have perfected our offshore delivery system, working with some of the world’s largest STM publishers.
Post: Pharmacovigilance Analyst
Job Description:
For this database the team will be supporting the client by:
1. Thoroughly reviewing the published reports / biomedical literature to ascertain if they contain a case report of an adverse reaction
2. Applying regulatory and internal guidance to determine if the article meets the definition of a case report.
3. Write accurate and concise summaries that captures the key elements from these published reports
4. 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
Candidate Profile:
We are looking for Pharmacovigilance Experts who can join our team in 30 days
Education Qualifications: MBBS only will be considered
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Ideal experience:
1. Minimum 1+ years of experience in Pharmacovigilance
2. Scanning scientific literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
3. 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.
4. Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities
Additional Information:
Education: MBBS, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance
End Date: 30th November, 2014
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