Job Description
- Safety Case Management, Medical Coding, and Operational Oversight
Manage ICSR (Individual Case Safety Report) case management teams or Encoding teams, ensuring operational readiness, quality, and compliance in intake, triage, entry, and analysis of cases, including encoding analysis across sites.
Identify and communicate technology or processes changes affecting case management workflows; coordinate readiness with teams, as needed.
Provide oversight of coding and vocabulary governance, ensuring alignment of terminology standard across programs and platforms; direct cross-functional harmonization initiatives; approve high-impact dictionary or terminology changes impacting multiple therapeutic areas.
Follow documentation, guidelines and regulations updates to maintain proficient data management and coding knowledge.
Showing an increasing capability for technical and process support to direct reports, ensuring they utilize appropriate resources for guidance.
- Quality, Compliance, and Inspection Readiness
Ensure all activities are in compliance with SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization- Good Clinical Practice), GxP and other regulatory requirements, and execution documents.
Monitor and interpret performance metrics to ensure that Compliance, Quality and Productivity goals are met.
Support audit/inspection readiness across multiple functions or regions, and ensure consistent documentation is in place.
- Collaboration, External Partnership, and Delivery Leadership.
Provide input on organizational management of SDM (Safety Data Management) resources and processes.
Align on priorities, and close feedback loops to drive high-quality and coordinated delivery.
- People Management Responsibilities
Set clear objectives aligned to organizational goals; assign work and set priorities.
Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring
- Technical skills: Safety Data Analysis and ICSR Technical Proficiency
- Fluent in English language capabilities, with advanced written and verbal communication for technical and business audiences.
- Proficient in pharmacovigilance operations and medical coding, leadership and oversight, including expertise of end-to-end process and relevant pharmacovigilance regulations.
- Capability of manage multi-site ICSR delivery with consistent quality standards.
- Knowledge of safety databases, AE (Adverse Event) data tools, and reporting mechanisms to secure compliance.
- Fluency in understanding clinical development processes, medical terminology, and safety reporting standards.
- Ability to interpret and apply performance metrics and quality standards effectively.
- Familiar with testing or validating new workflows or database configurations and knowledge of clinical and safety systems, dashboards, reporting tools, and coding platforms.
- Non-technical knowledge, skills, and abilities: Delivery Leadership, Communication, and Collaboration
- Leads and develops teams through motivation, feedback, and growth supporting.
- Applies analytical and organizational skills in decision making.
Demonstrates in adaptability, cultural awareness, and collaboration.
Facilitates communication and alignment with key stakeholders upstream and downstream. - Manages conflict constructively and ensures balanced team performance.
Empowers staff to take ownership and continuously improve outcomes.
High organizational, problem solving, and negotiation skills.
Understanding of the global aspect of SDM sites working as one organization. - Acts as change champion.
- Enterprise leadership skills
- Execution excellence: Translates strategic and regulatory priorities into clear operational objectives across multiple teams. Establishes performance standards, aligns resources, and ensures teams are accountable for delivering measurable, compliant, and sustainable results.
- Change Catalyst: Leads and sustains cross-functional change initiatives that advance strategic and regulatory priorities. Mobilizes teams, removes systemic barriers, and embeds new ways of working to ensure lasting adoption and measurable impact.
- Talent Growth: Developing talent; planning and supporting the developing of individuals' knowledge, skills and abilities so they can perform job adequately.
- Qualifications & Experience
- Required:
Bachelor's degree in Life Science and a minimum of 8 years experience in medical, life-science, or related field, including:
-4 years experience in a biopharmaceutical company
- People management experience (indirect of matrix leadership)
-Deep subject-matter expertise in relevant discipline
OR
- Advance degree (Masters or Doctorate) in Life Science and a minimum of 3 years of experienced in a medical, life-science, o related field, including:
-3 years experience in a biopharmaceutical company
-People management experience (indirect of matrix leadership)
-Deep subject-matter expertise in relevant discipline
- Brief description of the position
- The Manager of Safety Data Analyst (M-track) manages teams responsible for ICSR processing, analysis, and quality assurance, vocabulary governance and medical coding, along with ensuring operational excellence adhering to global guidance. This role oversees resource allocation and execution of SDM processes, performance metrics, and system readiness while promoting alignment with enterprise standards. The Manager drives team capability development and fosters collaboration across safety operations, IT, and process excellence functions to deliver reliable and high-quality safety data.
Required Skills:
Adaptability, Adaptability, Audit Readiness, Business Alignment, Career Planning, Clinical Data Management, Clinical Study Protocols, Compliance Activities, Data Analysis, Data Processing, Data Review, Data Security, Data Validation, Decision Making, Delivery Management, Enterprise Leadership, Executive Influence, Goal Setting, Good Clinical Data Management Practice (GCDMP), Key Performance Indicators (KPI), Matrix Management, Organizational Leadership, People Leadership, Performance Metrics, Pharmacovigilance {+ 10 more}
Preferred Skills:
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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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
no
Job Posting End Date:
10/31/2026
*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.