Principal Scientist, Drug Safety

Merck•North Wales, PA

6d•$231,900 - $365,000•Hybrid

About The Position

The CSRM Physician, Principal Scientist, is a physician leader in pharmacovigilance responsible for the clinical risk management and safety surveillance of assigned investigational and marketed products. Reporting to a CSRM Scientific Associate Vice President, CSRM Associate Vice President, or CSRM Distinguished Scientist, the role leads development and maintenance of risk management and pharmacovigilance plans and chairs the Risk Management and Safety Team for assigned products. The position partners with Clinical Development, Epidemiology, Regulatory Affairs, Biostatistics, Manufacturing, and other functions to develop integrated safety strategies, evaluate benefit-risk, and execute global pharmacovigilance and risk management activities. It has global scope across product development, regulatory review, and post-approval safety. The position may be based in Upper Gwynedd, Pennsylvania, or Rahway, New Jersey, is hybrid, and requires approximately 10% travel. It is an individual contributor role with no direct reports or budgetary responsibility.

Requirements

M.D., D.O., or equivalent medical degree.
At least 3 years of clinical experience following postgraduate medical training or other relevant clinical experience.
Excellent communication, writing, analytical, and organizational skills.
Demonstrated organizational leadership skills, preferably in clinical safety, pharmacovigilance, risk management, drug development, or a related area.
Ability to apply sound medical judgment to complex safety information and communicate clear benefit-risk assessments and recommendations.
Ability to collaborate effectively across functions and operate successfully in a global, matrixed organization.
Skills in Clinical Development, Clinical Risk Management, Clinical Safety, Cross-Functional Project Management, Detail-Oriented work, Medical Review, Medical Writing, Pharmacovigilance, Risk Management, Safety Evaluation, Safety Strategy, and Scientific Leadership.

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, participating in related internal and joint internal/external project teams as appropriate.
Partner with Clinical Development to ensure clinical programs support robust safety assessment of investigational compounds.
Work with Clinical Research and other partners to develop benefit-risk evaluations for aggregate safety reports and regulatory submissions.
Provide medical and scientific leadership in evaluating safety information throughout the product lifecycle.
Evaluate safety data from clinical trials, scientific literature, and post-approval use.
Lead safety surveillance for assigned products, including aggregate clinical trial data analyses and post-approval safety signal reviews.
Apply medical judgment to aggregate safety data and individual cases and collaborate with CSRM Associates in overseeing surveillance activities.
Ensure the completeness and medical accuracy of safety information in Company Core Data Sheets and oversee review and approval of product labeling files maintained in the safety database.
Use MedDRA and appropriate medical terminology in safety evaluation and documentation.
Lead development and maintenance of risk management and pharmacovigilance plans for assigned products.
Develop recommendations for pharmacovigilance actions, product labeling, risk minimization activities, and broader risk management strategies with CSRM Associates and cross-functional partners.
Provide scientific strategy and medical oversight for safety-related documents, including Common Technical Document components, Risk Management Plans, Periodic Safety Update Reports, aggregate reports, and regulatory filing summaries.
Ensure safety sections of Company product circulars are medically and scientifically appropriate.
Prepare safety summaries and analyses for regulatory documents and filings and, where applicable, oversee Medical Associates supporting safety data analysis and document authoring.
Collaborate with cross-functional stakeholders to align safety activities with global pharmacovigilance and risk management strategies.
Clearly communicate safety issues, benefit-risk considerations, and recommended actions to cross-functional teams and decisionmakers.
Participate in developing, implementing, and evaluating departmental standards, processes, metrics, and continuous improvement initiatives.
Contribute to a culture of scientific rigor, patient focus, accountability, and effective collaboration.