Senior Pharmacovigilance Leader - Risk & Safety

Merck; Topeka (KS); On-site; USD 282,000 - 444,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan and retirement benefits

Paid holidays and vacation

Sick days

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a CSRM Physician to lead pharmacovigilance and risk management for investigational and marketed products.

You will chair the Risk Management Safety Team and guide PV plans, integrating data from trials, literature, and post-approval use. The role involves cross-functional collaboration with clinical development, epidemiology, regulatory, statistics, and manufacturing to align safety strategies globally.

Qualifications

• MD/DO or equivalent required.
• Board Certification preferred.
• Experience in pharmacovigilance and risk management desired.

Responsibilities

• Lead safety surveillance activities for assigned products.
• Chair Risk Management Safety Team and contribute to PV plans.
• Collaborate with cross-functional teams on safety topics and regulatory documents.
• Develop safety summaries and analyses for regulatory filings and reports.
• Contribute to labeling recommendations and risk management plans.

Skills

Clinical Risk Management

Pharmacovigilance

Clinical Safety

Drug Development

Regulatory Documents

Communication Skills

Analytical Skills

Leadership

Education

MD/DO or equivalent

Board Certification (preferred)

Tools

MedDRA

Job description

Merck & Co., Inc. in Rahway, NJ seeks a CSRM Physician to lead pharmacovigilance and risk management for investigational and marketed products.

You will chair the Risk Management Safety Team and guide PV plans, integrating data from trials, literature, and post-approval use. The role involves cross-functional collaboration with clinical development, epidemiology, regulatory, statistics, and manufacturing to align safety strategies globally.