Director Drug Safety, Individual Case Medical Review

Job title: Director Drug Safety, Individual Case Medical Review

Company: MSD


Job description: Job DescriptionThe Director provides dynamic leadership and strategic direction with regards to high quality and excellent compliance of individual case safety reports (ICSRs) and, the performance and results of the Individual Case Medical Review (ICMR) personnel globally. This role has responsibilities for ensuring operational and scientific consistency, quality, development, and execution within the global ICMR organization. The focus of this role is strategic and operational with a broad scope and impact that includes ICMR oversight with regards to the performance and results of the ICMR personnel, as well as people management. This role has responsibilities for ensuring operational and scientific consistency, quality, development, and execution within the global ICMR organization, with a focus on the individual case medical safety review responsibilities.Key Responsibilities:Responsible for the supervision and performance management of one of the ICMR Therapeutic Area teams, specifically for business process execution of medical safety review activities, including timely completion, administrative issues management and oversightProvide leadership to the ICMR team by participating in the setting of vision, objectives, and goals for the ICMR personnel. Assume leadership role in ICMR, modeling responsibility, accountability, competency, initiative, and ethical behaviorResponsible for the evaluation of quality, compliance, and performance metrics to optimize work processes and to ensure inspection readiness and compliance for staff. Responsible for metrics and work distributionIn conjunction with the other ICMR managers, is responsible for ensuring the ICMR personnel perform as expected in their respective roles for all departmental activities.Responsible for the selection, training, supervision, development, and performance management of the specified ICMR Therapeutic Area teamResponsible for the medical safety review of individual case safety reportsCollaborate to provide input for the develop of SOPs, controlled documents, and continuous process improvements for the ICMR Organization, in partnership with cross functional areas, and in compliance with global and regional regulatory reporting requirementsParticipate as required as a member of the Risk Management Safety Team (RMST).May lead and/or participate in functional or cross functional projects as the ICMR subject matter expertRole may have several direct reportsEnergize, motivate, and establish a high performing team to aspire to excellenceCultivate a strong partnership with key stakeholders, including Global Pharmacovigilance Case Management (GPVCM), Global Clinical Development, and Global Regulatory Affairs. Partners with cross functional Global Clinical Safety & Pharmacovigilance (GCS&PV) Organizations including Clinical Safety Risk Management, Global PV Operations including Business DevelopmentProvide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of Therapeutic Area or program specific requirements.Build strong working relationships across the organization.STRATEGIC IMPACTBuild, lead, and maintain teams of high quality and complianceBuild high-performing teams that understand the key global regulations driving ICSR reportingProvides management with expert opinion within their area of expertise and responsibilityMay demonstrate ability to influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the divisionInteract with key stakeholders across department, division, and companyRole requires proactive approach, strategic thinking, and leadership to envision, plan and execute on organizational goalsDefine and drive strategic and forward-thinking approach to achieve global consistency of ICMR activities.SCOPE OF PEOPLE MANAGEMENT RESPONSIBILITYRole may have people management responsibilities for several direct reportsDevelop functional area resources, including recruitment, deployment, professional development, and performance evaluation of employeesHire, manage, and deploy resources as required to maintain and further develop the businessMay approve hiring of direct reports in all locations and ensures adequate training and mentoring of employeesEncourage strong collaboration cross-functionally both within GCS&PV as well as externally with other organizationsCreate an environment that attract, develop, and retain high quality employees.Required Experience and Skills:Minimum of 1 year experience in clinical medicine post training in patient care settings, with 3 years of experience preferredA minimum of 6 years of relevant work experience that may include both clinical medicine practice post training and pharmaceutical industry experience required, of which a minimum of 4 years must include relevant pharmaceutical, drug development related activities, with drug safety/pharmacovigilance experience preferredMinimum of 4 years of experience supervising/managing people/leading projects and/or teams preferredIndividual case medical review experience preferredProven ability to work effectively/collaboratively in a fast-paced environment and with all levels of personnel to drive resultsAbility to quickly adapt to changes in business priorities and effectively manage competing prioritiesProven organizational leadership with experience working cross culturally and actively supporting diversity both within the Company as well as external relationshipsAbility to think critically, conflict resolution, strategically, independently and problem solve.High level of motivation, drive, and demonstration of ethical leadership valuesExcellent written and verbal communication skills including ability to write clearly and concisely, with advanced English proficiencyStrong knowledge of GCP and ICH regulationsDemonstrated project management, and time management/organizational skills.Education:M.D. or equivalent Ex US Medical degree#GCSPV25Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 12/31/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Expected salary:

Location: Praha

Job date: Fri, 09 May 2025 07:09:04 GMT

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