Director, Medical Safety Review (Team Lead)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Under the direction and oversight of the Head of Medical Safety Review, the Team Lead for Medical Safety Review is:
- Responsible for the supervision and performance management of one of the Medical Safety Review (MSR) Teams, specifically for business process execution of medical safety review activities, including timely completing, administrative issues management and oversight. Role will have several direct reports.
- Provides leadership to the Medical Review team by participating in the setting of vision, objectives and goals for the Medical Safety Review Department. Assumes leadership role in MSR Team, modeling responsibility, accountability, competency, initiative, and ethical behavior.
- Under the direction of the Associate Vice President (AVP), Head of Medical Safety Review, is responsible for the evaluation of quality, compliance and performance metrics to optimize work processes and to ensure inspection readiness and compliance for staff.
- Under the direction of the AVP, Head of Medical Safety Review, and in conjunction with the Bogota MSR Sub Team lead, 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 Team. Responsible for the medical safety review of individual case safety reports.
- Collaborates with the Business Process Owners for both Clinical Trial Safety Reporting (CTSR) and MSR to develop SOPs, controlled documents and continuous process improvements for the Medical Safety Review team, in partnership with Global Safety Case Management, and in compliance with global and regional regulatory reporting requirements.
- Interacts with multiple stakeholders outside of MSR, in particular CTSR, Clinical Safety and Risk Management (CSRM), Global Safety, Global Regulatory Affairs and Clinical Directors.
- Participates as required as an extended member of the Risk Management Safety Team (RMST).
- May lead and/or participate in functional or cross functional projects as the MSR subject matter expert.
- M.D. or D.O. and equivalent
- Minimum of 3 years clinical practice experience, following training or prior industry experience in safety, clinical development and/or medical affairs
- Relevant Safety Systems Experience (i.e. Argus, ARIS-G, etc).
- Minimum 3 years People Management Experience
- Minimum of 8 years of professional experience and/or pharmaceutical industry experience required, of which a minimum of 2 years must include Medical Safety Review/Safety experience, as supervisor or individual contributor.
- Excellent writing and communication skills required.
- Effective presentation skills and experience influencing and negotiating required
- Interpretation of adverse experience information, regulatory guidance and inspection experience required.
- Demonstrated leadership skills in managing programs & processes, leading meetings and influencing peers and direct reports to drive results.
- Problem solving, conflict resolution and critical thinking skills are required.
- Experience managing and collaborating with global teams
- Awareness of local business practices and culture.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Drug Safety Surveillance (MD)
Employee Status: Regular
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Company Trade Name: Merck