Medical Reviewer - PSUR & Aggregate Reporting

Neptune Consultants
  • Mumbai
  • Confidential
  • 4-8 years
  • 26 Jun 2015

  • Medical Services

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

1. Prepares medical input to aggregate, clinical and safety regulatory reports

2. Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Company drugs.

3. Provides Pharmacovigilance input into updates of the Company Core Data Sheet.

4. Leads cross-functional teams, such as safety management teams and operational work groups [Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments]

5. Assist in evaluating and writing other safety deliverables including but not limited to clinical overviews, ad hoc health authority queries, drug safety product profile (DSPP), drug safety update report (DSUR)

6. Assist in providing safety input to DRA and clinical documents (e.g. core data sheet and investigator brochure)

7. Play an active role in standing and ad hoc Safety Management Team (SMT) and Safety Project Team (SPT) meetings

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Neptune Consultants