Principal Scientist, Drug Safety

MSD; North Wales (Montgomery County); Vor Ort; USD 232.000 - 365.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision coverage

401(k) retirement benefits

Paid holidays and vacation

Zusammenfassung

Merck & Co., Inc. is seeking a CSRM Physician, Principal Scientist to lead clinical safety and pharmacovigilance for approved and investigational products. This role sits at the intersection of medical strategy and regulatory execution, with global scope.

You will chair RMSTs, develop risk management plans, and guide safety analyses across product lifecycles, collaborating with cross-functional teams and external partners.

Qualifikationen

• MD/DO or equivalent medical degree required.
• Minimum of 3 years clinical experience after postgraduate training or relevant clinical experience.
• Excellent communication, writing, analytical, and organizational skills.
• Demonstrated leadership in clinical safety, pharmacovigilance, or drug development.
• Ability to apply medical judgment to safety information and communicate benefit-risk assessments.

Aufgaben

• Chair the RMST and lead safety surveillance for assigned products.
• Develop risk management and pharmacovigilance plans.
• Provide medical oversight for safety documents and regulatory filings.
• Collaborate across Clinical Development, Regulatory Affairs, Biostatistics, and Manufacturing.

Kenntnisse

Clinical Safety

Pharmacovigilance

Risk Management

Medical Writing

Cross-Functional PM

Safety Evaluation

Clinical Development

Medical Review

Scientific Leadership

Detail-Oriented

Ausbildung

MD/DO or equivalent

Tools

MedDRA

Jobbeschreibung

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

• Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.

The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.

We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is: USA - Pennsylvania - North Wales (Upper Gwynedd)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

The salary range for the primary location of this role is: $231,900.00 - $365,000.00

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): San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA

Our company 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 we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.