Director Drug Safety, Clinical Safety and Risk Management

Job title: Director Drug Safety, Clinical Safety and Risk Management

Company: MSD


Job description: Job DescriptionResponsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed products. As chairs of the Risk Management Safety Team (RMST), CSRM Director lead the development and maintenance of risk management and pharmacovigilance plans.The CSRM Director is responsible for the supervision and performance management of CSRM Medical Associates in conducting their work of risk management and safety surveillance. Assists departmental oversite including budget, product assignments, and department development initiatives. Key participant in business integration and process improvement work streams with cross functional involvement.Key Responsibilities:Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team (RMST), and other related sub-team participation, for assigned products. This may include participation in internal and joint internal/external research project teams relevant to ongoing clinical development (pediatric fillings, new markets) and the further study of marketed compoundsPartners with clinical development to ensure that clinical programs will support robust safety assessment of products ongoing clinical development. Works with Clinical Research to develop the benefit-risk evaluation in aggregate safety reportsWorks closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned productsDuties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g., clinical trials, literature and post-approval use and ensuring completeness of safety information in company core data sheets (CCDS)Accountable for scientific strategy for safety related documents (e.g., CTD components, Risk Management Plans (RMP) and Periodic Safety Update Reports) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriateResponsible for safety surveillance activities for assigned products such as aggregate data analysis and post approval safety signaling reviews, using medical judgment in review of aggregate data and individual cases. Collaborates with CSRM Associate and scientist in order to oversee all safety surveillance activities for assigned productsResponsible for risk management activities such as contributing to recommendations for pharmacovigilance actions, making recommendations for labelling, and developing the RMPs, pharmacovigilance strategies and risk minimization activities as warranted in collaboration with CSRM medical associate and scientistOversees the review and approval of product labelling files stored in the safety database and demonstrates a working knowledge of MedDRAPrepares safety summaries and analyses of safety related data for regulatory documents, aggregate reports, and summaries in support of regulatory filings and may supervise the activities of CSRM medical associates and scientists in the execution of safety data analysis and authoring of regulatory documentsParticipates in the development, implementation and evaluation of standards, processes, metrics, and other department initiativesAs a member of the CSRM department Leadership team, participates in the setting of vision, objectives, and goals for the departmentAssumes leadership role in CSRM, modelling responsibility, accountability, competency, initiative, and ethical behaviourResponsible for the selection, training, supervision, development, and performance management of direct reportsMentor and subject matter expert for direct reports regarding pharmacovigilance, risk management and departmental and company processesAs a people manager, the incumbent has direct influence on the department budget through oversight and approval of direct report expenses. Projects operational expenses and ensures compliance with departmental spending guidelines.Required Experience and Skills:Minimum of 2-3 years clinical experience (in a patient care setting) following post-graduate medical training or other relevant clinical experience6 years of relevant professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 4 years must include safety experience (e.g., PV or clinical) involving analysis of aggregate safety data and authoring of safety documentsPrior experience in clinical, pharmacological, or related fieldDemonstrated excellence in writing and communication skillsDemonstrated leadership skills in managing programs, processes, and facilitating meetingsDemonstrated excellence in Problem solving and critical thinking skillsExperience in process improvement initiatives preferredDemonstrated organizational leadership skillsExcellent communication, and writing skills in EnglishDemonstrated skills in managing programs, processes, and facilitating meetingsDemonstrated excellence in Problem solving, conflict resolution and critical thinking skillsEffective presentation skills and experience influencing and negotiating.Education:Required: Medical Doctor (MD)Preferred: Medical specialty#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 06:50:38 GMT

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