Senior Clinical Safety & Risk Management Scientist

MSD; Rahway (NJ); Hybrid; GBP 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work

Job summary

Merck & Co., Inc. in the United Kingdom seeks a CSRM Physician to lead pharmacovigilance and risk management for marketed products.

You will chair the RMST, collaborate with clinical development, epidemiology, regulatory affairs, and manufacturing to align safety strategies and review safety data from multiple sources. The role requires MD with extensive PV experience, strong leadership and English writing skills, and a track record in safety documentation such as RMPs and PSURs.

Qualifications

• Minimum 7 years of professional experience across clinical and pharmaceutical industry, with at least 4 years in safety (PV or clinical)
• Minimum 2–3 years of clinical experience post-graduate
• Demonstrated organizational leadership skills
• Excellent communication and writing skills in English
• Experience in managing pharmacovigilance programs, risk management and regulatory documents
• Proven ability to influence and negotiate with stakeholders

Responsibilities

• Chair RMST and lead safety topics for assigned products across cross-functional teams
• Oversee safety data evaluation from trials, literature, and post-approval use
• Develop scientific safety strategies for CTD components, RMPs and PSURs
• Lead safety surveillance activities including aggregate data analyses and safety signaling
• Contribute to labeling recommendations and pharmacovigilance risk minimization
• Review and approve product labeling files and safety content in CCDS
• Prepare safety summaries and regulatory documents; mentor CSRM associates
• Support development and evaluation of PK/PD, processes, and safety metrics

Skills

ADR Monitoring

Analytical Thinking

Clinical Experience

Clinical Judgment

Data Analysis

Pharmacovigilance

Regulatory Interpretation

Risk Management

Communication Skills

Education

Medical Doctor (MD)

Job description

Merck & Co., Inc. in the United Kingdom seeks a CSRM Physician to lead pharmacovigilance and risk management for marketed products.

You will chair the RMST, collaborate with clinical development, epidemiology, regulatory affairs, and manufacturing to align safety strategies and review safety data from multiple sources. The role requires MD with extensive PV experience, strong leadership and English writing skills, and a track record in safety documentation such as RMPs and PSURs.