Job Title

Project role: Associate Medical Safety Director Work experiences: 5+ years. Work location: PAN India Mode of work: Home based Shift: 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 Functions 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 summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve 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 product’s safety profile Provide 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 meetings Provide 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 Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review 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 requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain 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 Req Three (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 Req 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 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.