Senior Pharmacovigilance Scientist & Safety Lead

Merck; Denver (CO); On-site; USD 282,000 - 444,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision insurance

401(k)

Job summary

Merck is seeking a CSRM Physician in Rahway, NJ to lead safety surveillance and risk management for investigational and marketed products. You will chair risk management teams, collaborate with clinical development, epidemiology, regulatory affairs, and manufacturing to align safety strategies globally.

The role requires MD/DO with 3+ years clinical/pharmacovigilance experience, strong leadership, and excellent communication.

Qualifications

• MD/DO or equivalent required for clinical leadership in pharmacovigilance.
• Experience in drug development, safety surveillance and regulatory documents is essential.
• Strong leadership and cross-functional collaboration skills are expected.
• Excellent written and verbal communication and analytical abilities are required.

Responsibilities

• Lead the Risk Management Safety Team and participate in Product Development Teams.
• Develop and maintain risk management and pharmacovigilance plans for assigned products.
• Ensure safety evaluation across trials, literature, and post-approval data is complete and accurate.
• Contribute to CTD components, Risk Management Plans, and periodic safety update reports.
• Advise on labeling changes and pharmacovigilance strategies with CSRM colleagues.
• Prepare safety summaries for regulatory filings and supervise medical associates as needed.
• Help define standards, processes, metrics, and department initiatives.

Skills

Clinical development

Clinical risk management

Clinical safety

Pharmacovigilance

Drug development

Regulatory documents

Risk management

Safety assessment reports

Education

MD/DO or equivalent

Board Certification (preferred)

Job description

Merck is seeking a CSRM Physician in Rahway, NJ to lead safety surveillance and risk management for investigational and marketed products. You will chair risk management teams, collaborate with clinical development, epidemiology, regulatory affairs, and manufacturing to align safety strategies globally.

The role requires MD/DO with 3+ years clinical/pharmacovigilance experience, strong leadership, and excellent communication.