Job Description

Responsible 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 compounds

• Partners 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 reports

• Works 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 products

• Duties 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 appropriate

• Responsible 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 products

• Responsible 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 scientist

• Oversees the review and approval of product labelling files stored in the safety database and demonstrates a working knowledge of MedDRA

• Prepares 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 documents

• Participates in the development, implementation and evaluation of standards, processes, metrics, and other department initiatives

• As a member of the CSRM department Leadership team, participates in the setting of vision, objectives, and goals for the department

• Assumes leadership role in CSRM, modelling responsibility, accountability, competency, initiative, and ethical behaviour

• Responsible for the selection, training, supervision, development, and performance management of direct reports

• Mentor and subject matter expert for direct reports regarding pharmacovigilance, risk management and departmental and company processes

• As 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 experience

• 6 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 documents

• Prior experience in clinical, pharmacological, or related field

• Demonstrated excellence in writing and communication skills

• Demonstrated leadership skills in managing programs, processes, and facilitating meetings

• Demonstrated excellence in Problem solving and critical thinking skills

• Experience in process improvement initiatives preferred

• Demonstrated organizational leadership skills

• Excellent communication, and writing skills in English

• Demonstrated skills in managing programs, processes, and facilitating meetings

• Demonstrated excellence in Problem solving, conflict resolution and critical thinking skills

• Effective presentation skills and experience influencing and negotiating.

Education:

• Required: Medical Doctor (MD)

• Preferred: Medical specialty

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