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medical Safety Advisor

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summaryCompose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirementsServe as an internal consultant to pharmacovigilance case processing teams on projects being supportedProvide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profileProvide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical dataRepresent safety and clinical data review findings during client meetingsReview and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contractPerform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.Act as Global Safety Physician or Assistant or Back-up on projects as assignedAttend project meetings, medical safety team meetings, and client meetings as requestedEnsure coverage for all medical safety deliverables within regulatory or contracted timelinesProvide medical escalation support for medical information projectsProvide medical escalation support for EU Qualified Persons for Pharmacovigilance projects24 hour medical support as required on assigned projectsMaintain awareness of medical-safety-regulatory industry developmentsAll responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIESKnowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practiceKnowledge of clinical trials and pharmaceutical research processAbility to establish and meet priorities, deadlines, and objectives.Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.Ability to establish and maintain effective working relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCEA medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education and 3 years experience practicing clinical medicine after award of medical degree; or equivalent combination of education, training and experience.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: MBBS

Experience: 5-9


Bio/Pharma Informatics | Clinical Research | Drug Regulation | Pharmaceutical Research
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