Senior Pharmacovigilance Leader: Safety & Risk Mgmt

Merck; Helena (MT); Remote; USD 282,000 - 444,000; Full time

Job summary

Merck is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned investigational and marketed products. You will chair the Risk Management Safety Team and oversee safety data evaluation across trials, literature, and post-approval use.

You will collaborate with cross-functional teams including clinical development, regulatory affairs, epidemiology, statistics, and manufacturing to implement safety surveillance and risk minimization strategies.

Qualifications

• MD/DO or equivalent medical degree.
• Board certification preferred.
• Minimum of 3 years clinical experience after post-graduate training or other relevant clinical experience.
• Experience in drug development and pharmacovigilance.
• Strong organizational, writing and communication skills.

Responsibilities

• Lead pharmacovigilance and risk management activities for assigned products.
• Chair Risk Management and Safety Team and participate in product development teams.
• Collaborate with clinical development, regulatory affairs, epidemiology, statistics, and manufacturing to align safety efforts.
• Evaluate safety data from trials, literature, and post-approval use.
• Prepare safety summaries and regulatory safety documents.
• Contribute to development of Risk Management Plans and labeling recommendations.

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)

Tools

MedDRA

Job description

Merck is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned investigational and marketed products. You will chair the Risk Management Safety Team and oversee safety data evaluation across trials, literature, and post-approval use.

You will collaborate with cross-functional teams including clinical development, regulatory affairs, epidemiology, statistics, and manufacturing to implement safety surveillance and risk minimization strategies.