Senior Pharmacovigilance & Risk Lead (Remote)

Merck; Pierre (SD); Remote; USD 282,000 - 444,000; Full time

Job summary

Merck in Rahway, NJ, is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products, chair the Risk Management and Safety Team, and guide safety surveillance across development and post‑approval programs.

The role collaborates with cross‑functional teams, evaluates safety data from trials, literature and real‑world use, and prepares safety analyses and regulatory documents to support labeling and risk‑minimization strategies.

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 Risk Management and Safety Team and participate in sub-teams for assigned products.
• Collaborate with cross-functional teams in clinical development, epidemiology, regulatory, statistics, and manufacturing to manage safety topics.
• Oversee safety data evaluation from trials, literature, and post-approval use.
• Prepare safety summaries and regulatory documents and supervise CSRM associates.
• Develop and evaluate standards, processes, metrics, and department initiatives.

Skills

Clinical Development

Clinical Risk Management

Clinical Safety

Pharmacovigilance

Regulatory Documents

Drug Development

Safety Assessment

Education

MD/DO

Board Certification

Job description

Merck in Rahway, NJ, is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products, chair the Risk Management and Safety Team, and guide safety surveillance across development and post‑approval programs.

The role collaborates with cross‑functional teams, evaluates safety data from trials, literature and real‑world use, and prepares safety analyses and regulatory documents to support labeling and risk‑minimization strategies.