Director, Clinical Safety & Risk Management (Medical Assessment) Job
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 general direction of the Clinical Safety and Risk Management (CSRM) Physician, the CSRM Medical Assessment Physician is an expert in drug and/or vaccine safety and is responsible for the medical assessment of product quality observations / deviations for the Company’s marketed drugs and vaccines.
The incumbent will work closely with colleagues in Merck Manufacturing Division (MMD) Product Quality and Global Safety & Environment during the investigation of product quality complaint reports and GMP non-compliance events to evaluate potential patient safety impact, and provide medical subject matter expertise during Investigative Review, Fact-Finding and Recall meetings.
Partners with Risk Management Safety Teams to ensure efforts are aligned with global risk management strategies for Company products.
This role will work with the CSRM Group Lead to plan and implement the evolving direction for the medical assessment function of the department, as well as helping develop and align processes to support the department objectives.
- MD/DO or equivalent
- Minimum three (3) years Clinical experience
- Must have excellent communication, writing and analytic skills
- Drug safety / pharmacovigilance, pharmaceutical industry experience
- Board certification highly desirable
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
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck