Senior Principal Scientist, Pharmacovigilance & Risk

Merck; Richmond (VA); Remote; USD 282,000 - 444,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

Merck in Rahway, NJ is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products. You will chair safety teams, oversee safety data evaluation from trials and literature, and guide risk management plans in collaboration with cross-functional teams.

The role requires an MD/DO with 3+ years in clinical safety/pharmacovigilance and strong leadership, communication, and analytical skills. A flexible work arrangement including remote options is available.

Qualifications

• MD, DO, or equivalent medical degree.
• Minimum 3 years clinical experience post-graduate.
• Experience in drug development or regulatory.
• Experience in clinical safety, pharmacovigilance and/or risk management.
• Strong leadership and communication skills.

Responsibilities

• Lead the Risk Management Safety Team and pharmacovigilance plans for assigned products.
• Collaborate with cross-functional teams to ensure safety topics are addressed across development and post-approval.
• Prepare safety summaries and analyses for regulatory filings and reports.
• Review product labeling files and safety data, ensuring accuracy in MedDRA terms.
• Develop and maintain safety documents (CTD components, RMPs, PSURs) and risk minimization strategies.
• Oversee safety surveillance activities and data analyses for assigned products.

Skills

Clinical Safety

Pharmacovigilance

Risk Management

Drug Development

Regulatory Documents

Medical Writing

Education

MD/DO or equivalent

Board Certification preferred

Tools

MedDRA knowledge

Job description

Merck in Rahway, NJ is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products. You will chair safety teams, oversee safety data evaluation from trials and literature, and guide risk management plans in collaboration with cross-functional teams.

The role requires an MD/DO with 3+ years in clinical safety/pharmacovigilance and strong leadership, communication, and analytical skills. A flexible work arrangement including remote options is available.