Job Title

Project role : Associate Medical Safety DirectorWork experiences : 5+ years.Work location : PAN IndiaMode of work : Home basedShift : Should be flexible in afternoon shift.Must have skills : end-to-end signal management activities.Job overview : Provide 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 stand alone 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 product’s 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 MeetingsAttends 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 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 developmentsQualifications:Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education ReqThree (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience ReqKnowledge 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 flexibilityAbility to establish and maintain effective working relationships with coworkers, managers and clientsA valid medical license, or equivalent, from the country or region in which he/she resides and works PrefJob Responsibility:Oversight of clinical deliverables across all trial phases (start-up to close-out).Development and review of study management plans, risk assessments, and analytics strategies.Monitoring of site performance, key risk indicators (KRIs), and operational triggers.Financial oversight including budget tracking and investigator payments.Coordination of cross-functional teams to meet project milestones.Quality assurance through regular audits, documentation, and compliance checks. Leading data review processes and ensuring audit readiness at all times.May require taking up Clinical lead activities, Manage Finance related information (budget, CO etc.), Manage project resources (CRAs/CTAs/Centralized monitoring team), Conduct periodic review of site activities.Act as lead for the reviewers performing Subject Level Data Review, create plans and Act as Subject Matter Expert to support the CMS department in delivering trainings, perform periodic review of Centralized monitoring trainings.Act as mentor or coach for Technical solution Specialist (TSS).;Monitor site performance and make recommendations for timely corrective actions.Technical Skills:Requires minimum of 5 years of relevant experience or Medical degree with a minimum 4 years of clinical trial experience or equivalent combination of education, training and experience. Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements. i.e., International Conference on Harmonisation - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.Good Clinical system expertise.