Senior Principal Scientist, Drug Safety

Merck•Rahway, NJ

5h•$282,200 - $444,200•Remote

About The Position

The CSRM Physician is a pharmacovigilance leader responsible for clinical risk management and safety surveillance for assigned investigational and marketed products. The role chairs the Risk Management and Safety Team and leads the development and maintenance of risk management and pharmacovigilance plans. The position contributes to product development teams and related research and sub-teams, partnering with clinical development and clinical research to support robust safety assessment and benefit-risk evaluation. It works cross-functionally with clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to align safety activities with global pharmacovigilance and risk management strategies. The CSRM Physician evaluates safety information from clinical trials, literature, post-approval use, aggregate data, and individual cases; supports complete company core data sheets; and develops scientific strategy for safety-related regulatory documents and product labeling. The role oversees safety surveillance and risk management activities, including safety signaling reviews, labeling recommendations, risk management plans, pharmacovigilance strategies, and risk minimization activities. It also prepares safety analyses and summaries for regulatory documents and may supervise CSRM medical associates. The role participates in developing, implementing, and evaluating department standards, processes, metrics, and initiatives.

Requirements

MD, DO, or equivalent degree.
At least 3 years of clinical experience following postgraduate medical training, or other relevant clinical experience.
Prior experience in drug development, which may include clinical development and/or regulatory experience.
Experience in clinical safety, pharmacovigilance, and/or risk management.
Demonstrated organizational leadership skills, preferably in the noted employment areas.
Excellent communication, writing, and analytical skills.
Required skills: Clinical Development, Clinical Risk Management, Clinical Safety, Clinical Training, Drug Development, Drug Safety Surveillance, Pharmacovigilance, Regulatory Documents, Risk Management, and Safety Assessment Reports.

Nice To Haves

Board certification.

Responsibilities

Serve as a core member of Product Development Teams and chair the Risk Management and Safety Team for assigned products.
Participate in internal and joint internal/external research project teams relevant to developing new compounds and further studying marketed compounds.
Partner with clinical development to ensure clinical programs support robust safety assessment of investigational compounds.
Work with Clinical Research to develop benefit-risk evaluations in aggregate safety reports.
Coordinate with cross-functional partners to manage safety topics and align activities with global pharmacovigilance and risk management strategies.
Evaluate safety data from clinical trials, literature, and post-approval use, and ensure completeness of safety information in company core data sheets.
Develop scientific strategy for safety-related documents, including CTD components, Risk Management Plans, and Periodic Safety Update Reports.
Ensure safety sections of Company product circulars are medically and scientifically appropriate.
Conduct safety surveillance, including aggregate clinical trial data analyses and post-approval safety signaling reviews, using medical judgment in reviewing aggregate data and individual cases.
Collaborate with the CSRM Associate in overseeing safety surveillance activities.
Recommend pharmacovigilance actions and labeling, and develop Risk Management Plans, pharmacovigilance strategies, and risk minimization activities with the CSRM Associate.
Oversee review and approval of product labeling files stored in the safety database.
Prepare safety summaries and analyses for regulatory documents, aggregate reports, and regulatory filing support.
May supervise CSRM medical associates performing safety data analyses and authoring regulatory documents.
Participate in developing, implementing, and evaluating department standards, processes, metrics, and other initiatives.