Principal Scientist, Drug Safety

Job Description

CSRM Physician, Principal Scientist

The CSRM Physician, Principal Scientist, is a physician leader in pharmacovigilance responsible for the overall 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, this role leads the development and maintenance of risk management and pharmacovigilance plans and chairs the Risk Management and Safety Team (RMST) for assigned products. The CSRM Physician partners closely with colleagues across Clinical Development, Epidemiology, Regulatory Affairs, Biostatistics, Manufacturing, and other functions to ensure integrated safety strategies, robust benefit-risk evaluation, and timely execution of global pharmacovigilance and risk management activities.

The position has global scope and supports product development, regulatory review, and post-approval safety activities. The role may be based in Upper Gwynedd, Pennsylvania, or Rahway, New Jersey, and requires approximately 10% travel. This is an individual contributor position with no direct reports or budgetary responsibility.

Key Responsibilities:

Clinical Safety and Product Development Leadership

Serve as a core member of Product Development Teams and chair the RMST for assigned products, with participation on 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 for the ongoing evaluation of safety information throughout the product lifecycle.

Safety Surveillance and Signal Management:

Evaluate safety data from multiple sources, including clinical trials, scientific literature, and post-approval use.

Lead safety surveillance activities for assigned products, including aggregate clinical trial data analyses and post-approval safety signaling reviews.

Apply medical judgment to the review of 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 the review and approval of product labeling files maintained in the safety database.

Demonstrate a working knowledge of MedDRA and apply appropriate medical terminology in safety evaluation and documentation.

Risk Management and Regulatory Documentation:

Lead the 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 in collaboration 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, as applicable, oversee Medical Associates supporting safety data analysis and document authoring.

Cross-Functional Collaboration and Organizational Contribution:

Collaborate with Clinical Development, Epidemiology, Regulatory Affairs, Biostatistics, Manufacturing, and other stakeholders to align safety activities with global pharmacovigilance and risk management strategies.

Communicate safety issues, benefit-risk considerations, and recommended actions clearly to cross-functional teams and decisionmakers.

Participate in the development, implementation, and evaluation of departmental standards, processes, metrics, and continuous improvement initiatives.

Contribute to a culture of scientific rigor, patient focus, accountability, and effective collaboration.

Education:

Required

M.D., D.O., or equivalent medical degree.

Preferred

Board Certification.

Required Experience and Skills:

Minimum of 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.

Required Skills:

Clinical Development, Clinical Risk Management, Clinical Safety, Cross-Functional Project Management, Detail-Oriented, Medical Review, Medical Writing, Pharmacovigilance, Risk Management, Safety Evaluation, Safety Strategy, Scientific Leadership

Preferred Skills:

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The primary location for this posting is:

• USA - Pennsylvania - North Wales (Upper Gwynedd)
• Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

• $231,900.00 - $365,000.00
• This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the