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: Scientific and Medical Writer – Experienced
Job Description
Required background and experience: you will have working experience in the pharmacovigilance/drug 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
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 authority.
Candidate Profile
Minimum 1+ years of experience in Pharmacovigilance
Scanning scientific literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities
Knowledge of global pharmacological regulations
Excellent command over English language (written and verbal)
Decent knowledge of ICH guidelines and regulations relating to safety reporting
Interview Process
Screening – Candidates appear for Language and Technical tests
First round – Telephonic/Personal Interview with Team Lead includes Technical questions and topics and assessing your skills for the position
Second round – Skype/Personal Interview with Sr. manager to determine your suitability for a particular group within the division you have applied to
HR round – Discussing Company policies and salary expectations. If you are successful in the interviews an offer is rolled out along with compensation structure and other rules related to employment
Additional Information:
Experience: 1-3 years
Education: B.Pharm, B.Sc, M.Pharm, BDS, BHMS, BAMS, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writer
End Date: 1st February, 2016
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