Director, Safety Data Analyst (M-Track)

Job description

Job Description The Director, Safety Data Analyst (M-Track) provides strategic and operational leadership for global Safety Data Management (SDM), ensuring excellence in pharmacovigilance case management, medical coding, compliance, quality oversight, and system enablement. This role drives process innovation, inspection readiness, digital transformation, and operational effectiveness while leading high-performing teams and partnering across Global Clinical Safety & Pharmacovigilance, Technology, and Data organizations. Key ResponsibilitiesStrategic Leadership & Operational Excellence Lead global Safety Data Management processes, governance, and documentation to ensure compliance, quality, and inspection readiness. Drive continuous improvement, simplification, and automation of SDM processes and technologies. Provide strategic direction for safety case management, medical coding, and operational performance across geographies. Monitor industry, regulatory, and technology developments and translate them into business improvements. Quality, Compliance & Inspection Readiness Ensure adherence to SOPs, GxP, ICH-GCP, pharmacovigilance regulations, and enterprise standards. Oversee quality management activities, governance frameworks, training strategies, and process controls. Support regulatory inspections, audits, CAPA management, and resolution of compliance findings. Maintain global consistency across documentation, training, and operational practices. Technology & Cross-Functional Leadership Partner with Global Clinical Safety & Pharmacovigilance, GDIA, IT, and vendors to optimize systems, workflows, automation, and data integration. Influence technology roadmaps, system enhancements, and digital capabilities that improve efficiency and compliance. Lead implementation of system releases and process changes to ensure business continuity and operational readiness. Develop business cases and recommendations to support investment and prioritization decisions. People Leadership Lead and develop a high-performing global organization through coaching, succession planning, talent development, and performance management. Establish clear goals, priorities, and accountability aligned with organizational strategy. Partner with HR on recruitment, workforce planning, employee relations, and organizational capability building. Manage resources and budgets to ensure effective delivery against business priorities. Qualifications & ExperienceRequired Bachelor's degree with 10+ years, or Advanced degree with 8+ years of relevant experience, including significant biopharmaceutical industry experience and 3+ years of people leadership experience. Deep expertise in ICSR management, medical coding, pharmacovigilance regulations, and Safety Data Management. Strong understanding of safety systems, coding platforms, reporting tools, automation, and system validation. Experience leading regulatory inspections, audits, quality oversight, and operational performance management. Knowledge of resource planning, capacity management, and process optimization. Exceptional communication and stakeholder management skills. Proven ability to lead through influence in complex global environments. Strong strategic thinking, problem-solving, and change management capabilities. Demonstrated success building collaborative, inclusive, and high-performing teams. Ability to translate complex scientific, medical, and regulatory information into business decisions. Required Skills: Adaptability, Adaptability, Case Management, Clinical Data Management, Data Validation, Decision Making, eCRF, Ethical Standards, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Medical Insurance Coding, Mentoring Staff, Metadata Management, Mitigated Risks, Organizational Performance Management, People Leadership, Pharmacovigilance, Process Standardization, Psychological Safety, Risk Mitigation Strategies, Standard Operating Procedure (SOP), Strategic Leadership, Strategic Thinking, Study Data Tabulation Model (SDTM), System Validation {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 08/13/2026*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.