Senior Pharmacovigilance Scientist & Safety Lead (Remote)

Merck; Bismarck (ND); Remote; USD 282,000 - 444,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan

Paid holidays and vacation

Annual bonus program

Job summary

Merck is seeking a CSRM Physician to lead pharmacovigilance, safety surveillance and risk management activities for assigned products. The role chairs the Risk Management Safety Team and collaborates with clinical development, regulatory, epidemiology and manufacturing to align safety strategies globally.

Responsibilities include safety data evaluation from multiple sources, developing risk management plans, and coordinating with medical associates on data analysis and regulatory documents.

Qualifications

• MD, DO, or equivalent required.
• Board Certification preferred.
• Minimum of 3 years clinical experience after post-graduate medical training or other relevant clinical experience.
• Experience in drug development (clinical development and/or regulatory).
• Experience in clinical safety, pharmacovigilance and/or risk management.
• Demonstrated leadership and strong communication, writing and analytic skills.

Responsibilities

• Lead pharmacovigilance and risk management activities for assigned products.
• Chair Risk Management Safety Team and collaborate with cross-functional teams.
• Develop and maintain risk management and pharmacovigilance plans and CTD components.
• Evaluate safety data from trials, literature and post-approval use for completeness in core data sheets.
• Prepare safety summaries and analyses for regulatory filings and reports.
• Contribute to labeling recommendations and risk management plans.

Skills

Clinical Development

Clinical Safety

Pharmacovigilance

Risk Management

Regulatory Documents

Safety Surveillance

Education

MD/DO or equivalent

Board Certification

Tools

MedDRA

Job description

Merck is seeking a CSRM Physician to lead pharmacovigilance, safety surveillance and risk management activities for assigned products. The role chairs the Risk Management Safety Team and collaborates with clinical development, regulatory, epidemiology and manufacturing to align safety strategies globally.

Responsibilities include safety data evaluation from multiple sources, developing risk management plans, and coordinating with medical associates on data analysis and regulatory documents.