Remote Senior Clinical Safety Leader, Pharmacovigilance

Merck; Phoenix (AZ); 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, chair the Risk Management Safety Team, and drive safety strategy across clinical development and regulatory filings. The role requires MD/DO or equivalent with 3+ years of clinical safety experience and board-certification preferred.

The position collaborates with Clinical Development, Epidemiology, Regulatory, and Manufacturing to ensure comprehensive safety assessments and robust risk

Qualifications

• MD, DO, or equivalent required
• Board Certification preferred
• Minimum of 3 years clinical experience after post-graduate training or relevant clinical experience
• Experience in drug development, clinical safety, pharmacovigilance and/or risk management
• Demonstrated organizational leadership skills
• Excellent written and oral communication and analytic abilities

Responsibilities

• Lead pharmacovigilance and risk management activities for assigned products.
• Chairs of Risk Management Safety Team; contributes to product development safety strategies.
• Collaborates with cross-functional teams (clinical development, epidemiology, regulatory, statistics, manufacturing) on safety topics.
• Evaluate safety data from trials, literature, and post-approval use for completeness and accuracy.
• Develop CTD components, Risk Management Plans and Periodic Safety Update Reports; oversee safety documents.

Skills

Clinical Safety

Pharmacovigilance

Drug Development

Regulatory Documents

Risk Management

Safety Data Analysis

Education

MD/DO or equivalent

Board Certification

Job description

Merck is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products, chair the Risk Management Safety Team, and drive safety strategy across clinical development and regulatory filings. The role requires MD/DO or equivalent with 3+ years of clinical safety experience and board-certification preferred.

The position collaborates with Clinical Development, Epidemiology, Regulatory, and Manufacturing to ensure comprehensive safety assessments and robust risk