Associate Medical Safety Director

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 developments Qualifications 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 Pref IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at