Clinical Safety Risk Management Physician
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 a Clinical Safety and Risk Management (CSRM) Team Lead, the CSRM Physician is an expert in drug and/or vaccine safety and is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed drugs/vaccines.
Key responsibilities include but are not limited to the following:
- Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team, and other related sub-team participation, for assigned products. This may include participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
- Partners with clinical development to ensure that clinical programs will support robust safety assessment of our investigational compounds.
- The CSRM Senior Principal Scientist may work closely with a cross-functional group of experts in epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet our global pharmacovigilance and risk management strategies for assigned products.
- Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use
- Accountable for scientific strategy for safety related documents (e.g. CTD components, RMPs and PBRERs) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
- Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of summary data and individual cases as well as overseeing the medical judgment of other staff.
- Responsible for the development of worldwide risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.
- The CSRM Senior Principal Scientist may supervise the activities of CSRM Staff in the execution of safety data analysis and medical writing.
- Works with CSRM Group Lead to plan direction for function of the department, helps develop departmental and enterprise processes (as assigned).
Minimum Education Requirement:
- MD/DO or equivalent
Required Experience and Skills:
- Minimum three (3) years clinical experience
- Experience in clinical safety, pharmacovigilance and/or risk management
- Must have excellent communication, writing and analytic skills
Preferred Experience and Skills:
- Industry experience in both an investigational and post-marketing capacity
- Board Certification is highly desirable
- Subspecialty in Epidemiology, or other related subspecialty preferred
- Training and/or experience in public health, epidemiology, and/or quantitative sciences
- Relevant therapeutic area experience preferred, but not required
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)
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Company Trade Name: Merck