Director Drug Safety, Individual Case Medical Review

Job Description

The Director provides dynamic leadership and strategic direction with regards to high quality and excellent compliance of individual case safety reports (ICSRs) and, the performance and results of the Individual Case Medical Review (ICMR) personnel globally. This role has responsibilities for ensuring operational and scientific consistency, quality, development, and execution within the global ICMR organization. The focus of this role is strategic and operational with a broad scope and impact that includes ICMR oversight with regards to the performance and results of the ICMR personnel, as well as people management. This role has responsibilities for ensuring operational and scientific consistency, quality, development, and execution within the global ICMR organization, with a focus on the individual case medical safety review responsibilities.

Key Responsibilities:

• Responsible for the supervision and performance management of one of the ICMR Therapeutic Area teams, specifically for business process execution of medical safety review activities, including timely completion, administrative issues management and oversight
• Provide leadership to the ICMR team by participating in the setting of vision, objectives, and goals for the ICMR personnel. Assume leadership role in ICMR, modeling responsibility, accountability, competency, initiative, and ethical behavior
• Responsible for the evaluation of quality, compliance, and performance metrics to optimize work processes and to ensure inspection readiness and compliance for staff. Responsible for metrics and work distribution
• In conjunction with the other ICMR managers, is responsible for ensuring the ICMR personnel perform as expected in their respective roles for all departmental activities.
• Responsible for the selection, training, supervision, development, and performance management of the specified ICMR Therapeutic Area team
• Responsible for the medical safety review of individual case safety reports
• Collaborate to provide input for the develop of SOPs, controlled documents, and continuous process improvements for the ICMR Organization, in partnership with cross functional areas, and in compliance with global and regional regulatory reporting requirements
• Participate as required as a member of the Risk Management Safety Team (RMST).
• May lead and/or participate in functional or cross functional projects as the ICMR subject matter expert
• Role may have several direct reports
• Energize, motivate, and establish a high performing team to aspire to excellence
• Cultivate a strong partnership with key stakeholders, including Global Pharmacovigilance Case Management (GPVCM), Global Clinical Development, and Global Regulatory Affairs. Partners with cross functional Global Clinical Safety & Pharmacovigilance (GCS&PV) Organizations including Clinical Safety Risk Management, Global PV Operations including Business Development
• Provide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of Therapeutic Area or program specific requirements.
• Build strong working relationships across the organization.

STRATEGIC IMPACT

• Build, lead, and maintain teams of high quality and compliance
• Build high-performing teams that understand the key global regulations driving ICSR reporting
• Provides management with expert opinion within their area of expertise and responsibility
• May demonstrate ability to influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
• Interact with key stakeholders across department, division, and company
• Role requires proactive approach, strategic thinking, and leadership to envision, plan and execute on organizational goals
• Define and drive strategic and forward-thinking approach to achieve global consistency of ICMR activities.

SCOPE OF PEOPLE MANAGEMENT RESPONSIBILITY

• Role may have people management responsibilities for several direct reports
• Develop functional area resources, including recruitment, deployment, professional development, and performance evaluation of employees
• Hire, manage, and deploy resources as required to maintain and further develop the business
• May approve hiring of direct reports in all locations and ensures adequate training and mentoring of employees
• Encourage strong collaboration cross-functionally both within GCS&PV as well as externally with other organizations
• Create an environment that attract, develop, and retain high quality employees.

Required Experience and Skills:

• Minimum of 1 year experience in clinical medicine post training in patient care settings, with 3 years of experience preferred
• A minimum of 6 years of relevant work experience that may include both clinical medicine practice post training and pharmaceutical industry experience required, of which a minimum of 4 years must include relevant pharmaceutical, drug development related activities, with drug safety/pharmacovigilance experience preferred
• Minimum of 4 years of experience supervising/managing people/leading projects and/or teams preferred
• Individual case medical review experience preferred
• Proven ability to work effectively/collaboratively in a fast-paced environment and with all levels of personnel to drive results
• Ability to quickly adapt to changes in business priorities and effectively manage competing priorities
• Proven organizational leadership with experience working cross culturally and actively supporting diversity both within the Company as well as external relationships
• Ability to think critically, conflict resolution, strategically, independently and problem solve.
• High level of motivation, drive, and demonstration of ethical leadership values
• Excellent written and verbal communication skills including ability to write clearly and concisely, with advanced English proficiency
• Strong knowledge of GCP and ICH regulations
• Demonstrated project management, and time management/organizational skills.

Education:

• M.D. or equivalent Ex US Medical degree

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

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.

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