Senior Principal Scientist, Drug Safety

MSD • Rahway, NJ

1d • $282,200 - $444,200 • Remote

About The Position

The CSRM Physician leads pharmacovigilance and is responsible for overall clinical risk management and safety surveillance for assigned investigational and marketed products. As chair of the Risk Management and Safety Team, the physician leads the development and maintenance of risk management and pharmacovigilance plans.

The role contributes to product development through core membership on Product Development Teams, chairing Risk Management and Safety Teams, and participating in relevant sub-teams and research project teams. The CSRM Physician partners with clinical development to ensure clinical programs support robust safety assessment and works with Clinical Research on benefit-risk evaluation in aggregate safety reports. They collaborate across clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to align safety work with global pharmacovigilance and risk management strategies.

The position evaluates safety information from clinical trials, literature, and post-approval use; supports complete company core data sheets; and directs the scientific strategy for safety-related regulatory documents, including CTD components, Risk Management Plans, and Periodic Safety Update Reports. The physician conducts and oversees safety surveillance and risk management, including aggregate data analysis, post-approval signal reviews, labeling recommendations, and risk minimization activities. The role also prepares safety summaries and analyses for regulatory documents and may supervise CSRM medical associates. The position participates in developing, implementing, and evaluating departmental standards, processes, metrics, and initiatives.

Requirements

• MD, DO, or equivalent.
• 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 relevant employment areas.
• Excellent communication, writing, and analytical skills.
• Working knowledge of MedDRA.

Nice To Haves

• Board certification.

Responsibilities

• Participate in Product Development Teams as a core member, chair Risk Management and Safety Teams, and contribute to related sub-teams and research project teams.
• 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.
• Collaborate with cross-functional partners to manage safety topics and align work with global pharmacovigilance and risk management strategies.
• Evaluate safety data from clinical trials, literature, and post-approval use, and ensure safety information in company core data sheets is complete.
• Set the scientific strategy for safety-related regulatory 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 analysis and post-approval safety signal reviews, using medical judgment to review aggregate data and individual cases.
• Collaborate with the CSRM Associate in oversight of safety surveillance activities.
• Recommend pharmacovigilance actions and product labeling, and develop Risk Management Plans, pharmacovigilance strategies, and risk minimization activities with the CSRM Associate.
• Oversee review and approval of product labeling files in the safety database.
• Prepare safety summaries and analyses for regulatory documents, aggregate reports, and regulatory filing support.
• May supervise CSRM medical associates conducting safety data analysis and authoring regulatory documents.
• Participate in developing, implementing, and evaluating departmental standards, processes, metrics, and initiatives.

Benefits

• Medical, dental, vision, healthcare, and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree