Senior Principal Scientist, Pharmacovigilance & Risk

Merck; Rahway (NJ); Remote; USD 282,000 - 444,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Retirement benefits (401k)

Paid holidays & vacation

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products, coordinating safety surveillance across trials, literature, and post-approval data.

This role chairs the Risk Management Safety Team, develops safety strategies, and collaborates with cross-functional teams to ensure regulatory documents, labeling decisions, and risk minimization plans meet global standards.

Qualifications

• Minimum of 3 years clinical experience post-graduate medical training or other relevant clinical experience.
• Experience in drug development and safety data analysis.
• Excellent communication, writing and analytic skills.
• Demonstrated organizational leadership in related roles.

Responsibilities

• Lead on the Risk Management Safety Team and participate in Product Development Teams.
• Ensure safety assessment across trials, literature, and post-approval data.
• Collaborate with cross-functional teams to align pharmacovigilance strategies.
• Oversee safety data evaluation and regulatory documents.
• Develop Risk Management Plans and labeling recommendations.
• Prepare safety summaries for regulatory filings.

Skills

Clinical experience

Drug development

Pharmacovigilance

Leadership

Communication skills

Education

MD/DO or equivalent

Board Certification

Job description

Merck & Co., Inc. in Rahway, NJ is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products, coordinating safety surveillance across trials, literature, and post-approval data.

This role chairs the Risk Management Safety Team, develops safety strategies, and collaborates with cross-functional teams to ensure regulatory documents, labeling decisions, and risk minimization plans meet global standards.