Senior Clinical Safety & Risk Management Scientist

MSD; Rahway (NJ); Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck & Co., Inc. (MSD) in the United Kingdom is seeking a Clinical Safety and Risk Management Medical Associate Principal Scientist to lead medical review of serious AE reports and oversee pharmacovigilance activities under the CSRM physician.

Working in a hybrid role, you will collaborate with the RMST to develop risk management plans, respond to inquiries from health professionals and regulators, and contribute to PSUR/DSUR summaries and regulatory filings.

Qualifications

• MD degree and medical license; experience in pharmacovigilance highly preferred.
• Minimum 5 years professional experience with clinical and industry safety work.
• Strong English writing and communication skills.
• Experience in risk management and regulatory submissions.

Responsibilities

• Lead medical review of serious AE reports to monitor safety profile.
• Support CSRM physician in RMPs, REMS, and PSUR/DSUR preparation.
• Draft responses to inquiries from health professionals and regulators.
• Collaborate with RMST on data selection and analysis for safety issues.
• Represent CSRM in cross-functional teams and drive risk management initiatives.

Skills

Clinical judgment

Pharmacovigilance

Regulatory communications

Leadership

Writing skills

Data analysis

English communication

Project management

Education

MD

Tools

MS Office

Databases

Job description

Merck & Co., Inc. (MSD) in the United Kingdom is seeking a Clinical Safety and Risk Management Medical Associate Principal Scientist to lead medical review of serious AE reports and oversee pharmacovigilance activities under the CSRM physician.

Working in a hybrid role, you will collaborate with the RMST to develop risk management plans, respond to inquiries from health professionals and regulators, and contribute to PSUR/DSUR summaries and regulatory filings.