Senior Medical Safety Advisor

Job Title: Senior Medical Safety AdvisorEducation Qualification: MBBS/MD.Work Location: Anywhere in India.Work Mode: Home Based.Years of exp: 2yrs Clinical and 1+ yrs of Pharmacovigilance.Pls note MCI reg is mandatory for all the foreign medical graduates.Job OverviewProvide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and standalone safety projects with appropriate oversight from management or more senior medical safety directors.Essential FunctionsPerform 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 meetingsProvide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic ReportsProvide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation StrategiesProvide medical oversight for label development, review and changeProvide medical support and attendance at Data Safety Monitoring Board Meetings• Attends and contributes medical safety evaluation on Safety Monitoring CommitteesProvide medical safety contributions to the Integrated Safety Summary or Common Technical DocumentProvide medical review and edits to Drug Safety Reports or other benefit-risk assessmentsReview 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 coverages 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 projects• 24-hour medical support as required on assigned projectsMaintain awareness of medical-safety-regulatory industry developmentsQualificationsRequired MBBS/MD graduates from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.Three (3) years of clinical practice experience with 2+ additional years in the pharmaceutical or associated industry in any role is required.Knowledge 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 process.Ability 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.A valid medical license, or equivalent, from the country or region in which he/she resides and works Preferred.