Senior Pharmacovigilance Scientist & Risk Lead

Merck; Frankfort (KY); Remote; USD 282,000 - 444,000; Full time

Job summary

Merck is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products. You will chair the Risk Management Safety Team, guide safety surveillance, and coordinate cross-functional efforts across clinical development, regulatory, epidemiology, and manufacturing.

The role emphasizes safety data evaluation, CTD components, risk management planning, and collaboration to ensure robust safety programs and regulatory compliance globally.

Qualifications

• MD/DO or equivalent required.
• Board certification preferred.
• Minimum 3 years clinical experience after training or relevant clinical experience.
• Experience in drug development and pharmacovigilance.

Responsibilities

• Lead pharmacovigilance and risk management strategy for assigned products.
• Chairs of Risk Management Safety Team and oversees safety surveillance activities.
• Prepare safety summaries and regulatory documents; oversee labeling reviews.
• Collaborate with cross-functional teams to align safety strategies with global plans.

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 products. You will chair the Risk Management Safety Team, guide safety surveillance, and coordinate cross-functional efforts across clinical development, regulatory, epidemiology, and manufacturing.

The role emphasizes safety data evaluation, CTD components, risk management planning, and collaboration to ensure robust safety programs and regulatory compliance globally.