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Pharmacovigilance Physician

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

RESPONSIBILITIESPerform 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 summary Compose, 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 supported Provide 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 data Represent 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 contract Perform 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 assigned Attend project meetings, medical safety team meetings, and client meetings as requestedEnsure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projectsProvide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projectsMaintain awareness of medical-safety-regulatory industry developments 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 practice Knowledge 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 clients
Additional Degree: B.Sc. (Science) | MBBS

Experience: 5-10


Admin Services/Medical Facilities | Aged Care | Anaesthetist | Medical Rep.
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