Director, Drug Safety

hace 2 semanas

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

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 Medical Safety Review (MSR) Physicians in the US and globally.

This role has responsibilities for ensuring operational and scientific consistency, quality, development, and execution within the global Individual Case Medical Review (ICMR) organization.

The focus of this role is people management as well as strategic and operational with a broad scope and impact that includes MSR oversight with regards to the performance and results of the MSR Physicians.

This role has responsibilities for ensuring operational and scientific consistency, quality, development, and execution within the global ICMR organization, with a focus on the medical safety review responsibilities.


KEY ACCOUNTABILITIES

  • Responsible for the supervision and performance management of one of the MSR Therapeutic teams, specifically for business process execution of medical safety review activities, including timely completing, administrative issues management and oversight.
  • Provide leadership to the ICMR team by participating in the setting of vision, objectives, and goals for the Medical Safety Review physicians. 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 MSR managers, is responsible for ensuring the MSR physician performs as expected in their respective roles for all departmental activities.
  • Responsible for the selection, training, supervision, development, and performance management of the specified MSR Therapeutic 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).
  • Role will 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 Organizations including Clinical Safety Risk Management, Global Pharmacovigilance Ops including Business Development.
  • Build strong working relationships across the organization.

STRATEGIC IMPACT

  • Build, lead, and maintain teams of high quality and compliance.
  • Build highperforming 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 forwardthinking approach to achieve global consistency of ICMR activities.

SCOPE OF PEOPLE MANAGEMENT RESPONSIBILITY

  • Role will 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 crossfunctionally both within GCS&PV as well as externally with other organizations within and outside of the company
  • Create an environment that attract, develop, and retain high quality employees.

EDUCATION:

  • M.D./D.O. or equivalent Ex US Medical degree
  • Minimum of 1 year experience in clinical medicine, with 3 years of experience preferred.

WORK EXPERIENCE:

  • A minimum of 10 years of work experience to include clinical medicine experience and include at least 5 years of relevant pharmaceutical, drug development, drug safety/pharmacovigilance related activities, preferred.
  • Minimum of 5 years of experience supervising/managing/leading project and/or teams preferred.
  • Individual case medical review experience preferred.
  • Proven ability to work effectively/collaboratively in a fastpaced enviro

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