Job Description
- Responsibilities
- Safety Case Management, Medical Coding, and Operational Oversight
Manage ICSR (Individual Case Safety Report) case management teams, ensuring operational readiness, quality, and compliance in intake, triage, entry, and analysis of cases 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 standards 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.
Provide technical and process advice to direct reports, ensuring they utilize appropriate resources for guidance.
Support system roadmap and vendor governance, ensuring technology and data flows support functional and regulatory needs. - 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, ensure consistent documentation, and leads high-impact responses and corrective action strategies. - Collaboration, External Partnership, and Delivery Leadership.
Provide input on organizational management of SDM (Safety Data Management) resources to improve effectiveness and optimize utilization.
Act as a reliable partner with key business stakeholders, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, 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 advance written and verbal communication for technical and business audiences.
- Proficient in pharmacovigilance operations and medical coding leadership and oversight, including subject matter 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. - Experience with clinical development processes, medical terminology, and safety reporting standards.
- Expertise in resource planning, capacity modeling, and process optimization.
Ability to interpret and apply performance metrics and quality standards effectively. - Understanding of system testing, deployment readiness, and business case development.
- Highly 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 coaching.
- Applies strong analytical and organizational skills in decision making.
- Demonstrates adaptability, cultural awareness, and collaboration.
- Communicates persuasively with clarity and precision at all levels.
- Manages conflict constructively and ensures balanced team performance.
- Empowers staff to take ownership and continuously improve outcomes.
- Exceptional organizational, problem solving, and negotiation skills.
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.
- Coaching and Development Builds leadership capability by coaching direct reports, strengthening succession pipelines, and creating and environment where continuous development in embedded into daily operations.
- Qualifications & Experience
- Required:
Bachelor's degree in Life Science and a minimum of 8 years experience in medical, life-science, or related field, including:
-7 years experience in a biopharmaceutical company
-2 years people leadership and management experience (direct of matrix leadership)
-Deep subject-matter expertise in relevant discipline
OR
- Advance degree (Masters or Doctorate) in Life Science and a minimum of 4 years of experienced in a medical, life-science, o related field, including:
-3 years experience in a biopharmaceutical company
-2 years people leadership and management experience (direct of matrix leadership)
-Deep subject-matter expertise in relevant discipline
- Brief description of the position
- The associate Director of Safety Data Analyst (M-track) manages multi-site teams responsible for ICSR processing, analysis, and quality assurance, vocabulary governance and medical coding, along with ensuring operational excellence and consistency across geographies. This role oversees resource allocation, performance metrics, and system readiness while promoting alignment with enterprise standards. The Associate Director 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, Change Management, Clinical Data Management, Clinical Trials, Data Analysis, Data Extraction, Data Integration, Data Validation, Decision Making, Delivery Management, Enterprise Leadership, Goal Setting, Good Clinical Practice (GCP), Interpersonal Relationships, Key Performance Indicators (KPI), Leadership Management, Matrix Management, Organizational Leadership, People Leadership, Performance Metrics, Pharmacovigilance, PL/SQL (Programming Language) {+ 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.