Remote Senior Pharmacovigilance Scientist & Risk Lead

Merck; Hartford (CT); Remote; USD 282,000 - 444,000; Full time

Job summary

Merck is seeking a CSRM Physician to lead pharmacovigilance, oversee risk management, and drive safety surveillance for assigned products. This role chairs the Risk Management Safety Team and collaborates with clinical development, regulatory, epidemiology, statistics, and manufacturing to ensure comprehensive safety strategies.

Responsibilities include safety data evaluation from diverse sources, development of risk management plans, and preparation of regulatory documents.

Qualifications

• Minimum of 3 years clinical experience following post-graduate medical training or other relevant clinical experience.
• Prior experience in drug development (may include clinical development and/or regulatory)
• Experience in clinical safety, pharmacovigilance and/or risk management
• Demonstrated organizational leadership skills, preferably in the employment areas noted above.
• Excellent communication, writing and analytic skills

Responsibilities

• Lead pharmacovigilance and risk management activities for assigned products.
• Chair the Risk Management Safety Team and participate in product development teams.
• Collaborate with cross-functional teams across clinical development, regulatory affairs, epidemiology, stats and manufacturing.
• Oversee safety data evaluation from trials, literature, and post-approval use.
• Develop and maintain RS Plans, CTD components, and PSURs.
• Provide safety summaries and analyses for regulatory filings.
• Support labeling recommendations and risk minimization strategies.
• Contribute to department initiatives and process metrics.

Skills

Clinical Development

Clinical Risk Mgmt

Clinical Safety

Pharmacovigilance

Drug Development

Regulatory Documents

Risk Management

Safety Assessment

Leadership

Communication

Education

MD/DO or equivalent

Board Certification

Job description

Merck is seeking a CSRM Physician to lead pharmacovigilance, oversee risk management, and drive safety surveillance for assigned products. This role chairs the Risk Management Safety Team and collaborates with clinical development, regulatory, epidemiology, statistics, and manufacturing to ensure comprehensive safety strategies.

Responsibilities include safety data evaluation from diverse sources, development of risk management plans, and preparation of regulatory documents.