Associate Medical Safety and Data Review Director, Homebased - Iqvia Biotech in Bucuresti

IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.BASIC FUNCTIONS:The medical department consists of the Vice President, Medical; Senior Director, Medical Operations; Senior Directors, Medical; Senior Medical Directors and Medical Directors; Director Medical Safety and Data Review; Medical Data Review Director; Associate Medical Safety Directors; Medical Safety and Data Reviewers; Medical Operation Bidders; and Medical Monitor Operations Specialists. Primarily responsible for medical data review and medical safety case processing and related safety activities. Performs review of medical data to ensure medical/scientific plausibility and to employ medical assessment and knowledge. Also, provides medical expertise in assigned trials and standalone safety projects. Train and mentor team members in medical and safety review activities.ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:MEDICAL DATA REVIEW (MDR) RESPONSIBILITIESProvide medical review of data listings for Adverse Events, concomitant medications, medical history, eligibility criteria, protocol deviations, labs, vitals, ECGs and RECIST criteria, other study specific data, and patient profiles; preparation of periodic summary reports for safety data, Safety Trend Analysis Report (STAR)Provide outlier analysis and generate queries for missing/discrepant data through database lock Perform coding review of Serious Adverse Events, medical history, concomitant medication and AE line listings for accuracy and consistency Proficiency in the use of data listings, patient profiles, data analytic platforms, e.g.: Qlik Sense, and various EDCs systems including Medidata RAVE and INFORMPrepare periodic MDR summary reportsIdentify anomalies in patient reported data by performing Subject Level Data Review, querying clinical sites to determine accuracy as requiredProvide aggregate review of safety information including medical data, to maintain oversight of the Investigational product’s safety profile. Compose Safety Trend Analysis Report to summarize medical data reviewed and highlight critical findingsConduct in-stream data trend analysis in support of data quality and integrity including protocol compliance and targeted review of patient dataEnsure data quality focus to audit readiness with regulatory complianceProvide medical review of coded listings, such as adverse events, medical history, concomitant medications or other medical data listings to verify medical accuracy of clinical dataDefine data capture requirements in line with protocol and reporting needsSupport data analytics by reviewing the visualizations and identify and escalate potential issues of concernsPresent data at multi-disciplinary internal and/or client meetings as requiredMaintain strong customer relationshipsWith guidance, track performance and identify issues requiring remediation and their root causes, and implement remedial actions as requiredEnsure timely follow-up and resolution of compliance issuesServe as Subject Matter Expert (SME)Serve as Point of Contact/ back-up Point of Contact at program levelContinuously look for opportunities to improve efficiency of tasks and quality of deliverablesReview and contribute to Medical Data Review Plan and summary reportAttend Kick-Off Meetings, weekly team meetings, and client meetings, as required or requestedParticipate in activities involving risk assessment and measuring the effectiveness of risk minimization measuresDrive the delivery of end-to-end study data quality and integrityPerform special projects as requested by managementSAFETY REVIEW RESPONSIBILITIESMedical review and case assessment of SAEs including assessment and quality control of coding of preferred term, medical history, indications of concomitant medications and treatment medications; determination of seriousness, causality and expectedness; narrative review; query generation and follow up of SAEs till case closureCompose sponsor comment/summaryCompose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirementsServe as an internal consultant to Safety Management case processing teams on projects being supportedProvide coding review of AEs, medical history, concomitant medications or other medical data listings to verify and medically vet clinical dataRepresent safety and clinical data review findings during client meetingsReview and sign off on the Safety Management Plan per medical safety scope agreed in contractAttend project meetings, medical safety team meetings, and client meetings as requestedProvide support to line management in addressing any escalations related to quality of medical safety review or accuracy of medical safety assessment for awarded projectsEnsure coverage for all medical safety deliverables within regulatory or contracted timelinesMaintain awareness of medical safety regulatory developments in the industryWith guidance, track performance and identify issues requiring remediation and their root causes, and implement remedial actions as requiredEnsure timely follow-up and resolution of compliance issuesServe as Subject Matter Expert (SME)Serve as Point of Contact/ Back-up Point of contact at for medical team members or at program levelPerform special projects as requested by managementSPECIAL PROJECTS:May obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etcParticipation in a variety of team quality improvement efforts as necessaryTraining of newcomersSKILLS, AND ABILITIES:Ability to work in partnership with a multidisciplinary group of colleaguesOutstanding ability to work independently with minimal supervisionAbility to work effectively within a team and matrix environment, including coworkers, managers and clientsAbility to organize and work efficiently on several projects, each with specific requirements and/or shifting prioritiesExcellent oral and written communications skills and interpersonal skillsOutstanding customer focus skills for internal and external team membersAttention to detailStrong analytical skills and understanding of medical dataAbility to proactively identify issues of significanceWorking knowledge of medical terminology, pharmacology, anatomy, and physiologyMedical and operational focus towards metrics and status information, and aptitude to take appropriate actions for appropriate resolutionExcellent organizational and problem-solving skillsAbility to work on multiple projects and manage competing prioritiesAbility to plan and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time-based metricsExcellent coaching skillsKnowledge 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 processAbility to establish and meet priorities, deadlines, and objectivesAbility to show initiative and flexibility with assignmentsAbility to establish and maintain effective working relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCE:Medical degree from an accredited, internationally recognized medical school5 years’ experience in the practice of medicine in a clinical or academic setting which may include specialty medical training or fellowshipMinimum of 5 years’ experience in Medical Data Review and Medical Safety ReviewPHYSICAL REQUIREMENTS:Extensive use of telephone, email, and face-to-face communication requiring accurate perception and elocution of spoken and written EnglishExtensive use of keyboard requiring repetitive motion of fingersRegular sitting for extended periods of timeThe ability to travel based on client or company needs, <5% of time#LI-AP22IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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