Senior Medical Director, Drug Safety
3 weeks ago
Reporting to the Head of Global PV & Risk Management, the Senior Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). The individual will manage a group of medical safety professionals and PV scientists and will closely collaborate internally with other functions (e.g., Clinical Operations, Regulatory Affairs, Biostatistics, Clinical Development, and other Program Teams) and Contract Research Organizations (CROs) and Collaboration partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.JOB RESPONSIBILITESManage team of medical professionals and PV ScientistsProvide medical expertise/guidance in the assessment of ICSRs and aggregate drug safety reportsContribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reportsContribute to and Oversight of signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signalsServe as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI)Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documentsContribute to the development of Standard Operating Procedures, Working Instructions and other guidance documentsContribute to safety and pharmacovigilance training programs. Provide safety training at investigator meetingsCollaborate with Medical Monitors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trialsServe as a subject matter expert for vendors providing drug safety and pharmacovigilance servicesProvides strategic planning, implementation, and management of drug safety activities to support clinical development of the current pipeline.Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.Manages internal staff and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.The role will require some travel (approximately 10-15%), and hiring and managing peopleJOB REQUIREMENTSMedical Degree (MD) from recognized medical school with medical practice experience8+ years experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agencyExperience in managing Medical Professionals and PV ScientistsGood working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelinesDemonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activitiesProficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approvalExperience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labelsAbility to build relationships, collaborate and influence across disciplines within and outside stakeholdersExperience with MedDRA coding, Points to Consider, AoSE, and SMQsExcellent verbal, written and presentation skillNatural ability to communicate and influence effectively to varied audiencesAbility to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations while leading others through the ambiguity and changeDemonstrated ability to solve problems with innovative solutions along with strong organizational skillsPossess strong and dynamic leadership skills, with excellent written, verbal and presentation skillsEffective team player, who fosters collaboration within and across functional areasSound strategic evaluation, analysis, and decision-making skillsAbility to work in a dynamic, fast paced environment#J-18808-Ljbffr
by Jobble
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