Senior Principal Scientist, Pharmacovigilance & Risk Management

Merck; New Jersey; On-site; USD 180,000 - 280,000; Full time

Job summary

Merck seeks a CSRM Physician to lead pharmacovigilance, risk management, and safety surveillance for assigned products. You will chair the Risk Management Safety Team and guide safety strategies across trials, literature, and post‑marketing data.

You will collaborate with clinical development, regulatory, epidemiology, and manufacturing to ensure integration of safety plans, CTDs, and periodic safety update reports. MD/DO required with board certification preferred.

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 the Risk Management Safety Team and oversee development and maintenance of risk management and pharmacovigilance plans.
• Partner with clinical development to ensure safety assessments support robust program decisions.
• Collaborate with cross‑functional teams to manage safety topics and align with global pharmacovigilance strategies.
• Oversee safety data evaluation from multiple sources and ensure comprehensive safety information in core data sheets.
• Prepare safety summaries and analyses for regulatory documents and aggregate reports.

Skills

Clinical Development

Clinical Risk Management

Clinical Safety

Clinical Training

Drug Development

Drug Safety Surveillance

Pharmacovigilance

Regulatory Documents

Risk Management

Safety Assessment Reports

Education

MD/DO or equivalent

Board Certification

Job description

Merck seeks a CSRM Physician to lead pharmacovigilance, risk management, and safety surveillance for assigned products. You will chair the Risk Management Safety Team and guide safety strategies across trials, literature, and post‑marketing data.

You will collaborate with clinical development, regulatory, epidemiology, and manufacturing to ensure integration of safety plans, CTDs, and periodic safety update reports. MD/DO required with board certification preferred.