Associate Medical Data and Safety Review Director

pharmacovigilance and medical device safety with attention to regulatory regulations- Implement Medical Safety Review training strategy through the design and development of training modules, and medical safety mentorship- Provide IQVIA Biotech Medical Team members and contractors with training on serving in the role of study medical safety reviewer with ongoing support as required- Provide IQVIA Biotech Medical Department members and contractors with training on the use of the Argus Safety database with ongoing support as required- Implement Medical Data Review training strategy through development of training modules, and medical data mentorship- Provide new hire orientation of Medical Department members and contractors on the general principles of medical data review- Provide IQVIA Biotech Medical Department members and contractors with training to serve as study medical data reviewer with ongoing support as required- Communicate regular updates to line manager with prompt escalation of issues or concerns related to Medical staff training needs or staff performance to line manager and applicable Medical Leadership- Write and/or provide input to department specific SOPs and Working Practices- Perform other related duties as assigned or requested by line manager or other Medical Leadership- Liaise with Safety Management to review and establish shared best practices for excellence in collaborative Medical and Safety Management practices including interfacing with safety systems staff, safety line managers- Attend and present Medical Data Review activities during the client Kick Off Meeting- Write Medical Data Review Plan in collaboration with the Medical Monitor and in accordance with the client input- Create protocol specific Medical Data Review Guide in collaboration with the Medical Monitor- Participate in the internal eCRF review meeting and contribute to the development of eCRF- Define data capture requirements as required throughout the study that are consistent with the protocol and reporting needs- Contribute to the Data Review Plan- Provide requirements and specifications for programming of data listings- Collaborate with Clinical Science and Data Operations teams in the development of Qlik Sense builds and protocol specific customizations for patient profiles- Participate in activities involving risk assessment and measuring the effectiveness of risk minimization measures- Provide medical review of data listings and patient profiles, including but not limited to, adverse events, concomitant medications, medical history, labs, vitals, ECGs, eligibility criteria, efficacy assessments and study specific assessments- Prepare protocol specific templates for the periodic summary reports for safety data, including the Safety Trend Analysis Report (STAR) or Safety Review Committee slide presentations, in collaboration with the Medical Monitor- Compose the STAR report during the study according to scope and timelines- Conduct in-stream data trend analysis in support of data quality and integrity including protocol compliance and targeted review of patient data- Prepare periodic MDR summary reports or presentations if requested- Proficiency in use of data listings, patient profiles, data analytic platforms, e.g. Qlik Sense and various EDC systems including Medidata RAVE and INFORM- Provide aggregate review of safety information, to maintain oversight of the investigational product’s safety profile- Provide outlier analysis and generate queries for missing/discrepant data through database lock- Perform coding review of adverse events, medical history, concomitant medications and or other medical data listings for accuracy and consistency- Attend weekly team meetings, and client meetings, as required or requested- Present data at multi-disciplinary internal and/or client meetings as required- Ensure timely follow-up and resolution of compliance issues- Serve as Subject Matter Expert (SME)- Serve as Point of Contact/Back-up for medical team members on awarded projects- Continuously look for opportunities to improve efficiency of tasks and quality of deliverables- Drive the delivery of end-to-end study data quality and integrity- Perform special projects as requested by management- Medical review and case assessment of SAEs including assessment and coding of preferred term, medical history, indications of concomitant medications and treatment medications; determination of seriousness, causality, expectedness; narrative review; query generation and follow up of SAE till case closure- Compose sponsor comment/summary- Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements- Represent safety review findings during client meetings- Review and sign off on the Safety Management Plan per medical safety scope agreed in contract- Attend project meetings, medical safety team meetings, and client mee