Senior Principal Scientist, Pharmacovigilance Leader

Merck; Madison (WI); Remote; USD 282,000 - 444,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick leave

Job summary

Merck is seeking a CSRM Physician to lead pharmacovigilance and overall clinical risk management for assigned products. The role chairs the Risk Management Safety Team and shapes safety surveillance plans across development and post-approval stages.

You will collaborate with clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to ensure safety strategies align with global pharmacovigilance goals. Strong leadership and communication are essential.

Qualifications

• MD, DO, or equivalent required.
• Board Certification preferred.

Responsibilities

• Lead safety surveillance and pharmacovigilance activities for assigned products.
• Chair Risk Management Safety Team and develop risk management plans.
• Collaborate with cross-functional teams (clinical development, epidemiology, regulatory, statistics, manufacturing) to align safety strategies.
• Evaluate safety data from trials, literature, and post-approval use; ensure safe information in core data sheets.
• Prepare safety summaries and analyses for regulatory documents and submissions.
• Develop and implement standards, processes, and metrics for the department.

Skills

Clinical Development

Clinical Risk Management

Clinical Safety

Clinical Training

Drug Development

Drug Safety Surveillance

Pharmacovigilance

Regulatory Documents

Risk Management

Safety Assessment Reports

Education

MD, DO, or equivalent

Board Certification (preferred)

Job description

Merck is seeking a CSRM Physician to lead pharmacovigilance and overall clinical risk management for assigned products. The role chairs the Risk Management Safety Team and shapes safety surveillance plans across development and post-approval stages.

You will collaborate with clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to ensure safety strategies align with global pharmacovigilance goals. Strong leadership and communication are essential.