Senior Pharmacovigilance & Risk Lead

Merck & Co.; Upper Gwynedd Township (Montgomery County); Remote; USD 282,000 - 444,000; Full time

Benefits offered by this job

Medical, dental, vision insurance and

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. in Rahway, NJ seeks a CSRM Physician to lead pharmacovigilance, risk management and safety surveillance for assigned products, chairing safety teams and guiding regulatory submissions.

You will collaborate with clinical development, epidemiology, regulatory, statistics and manufacturing to ensure robust safety assessments, evaluate safety data from trials, literature and post-approval use, and contribute to Risk Management Plans.

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

• Engage in product development and chair Risk Management and Safety Team.
• Partner with clinical development to ensure safety assessment of programs.
• Collaborate with cross-functional teams to align pharmacovigilance strategies.
• Evaluate safety data from trials, literature and post-approval use.
• Prepare safety summaries for regulatory documents and periodic reports.
• Contribute to labeling recommendations and Risk Management Plans.
• Oversee review of product labeling files and MedDRA terminology.
• Lead pharmacovigilance actions, safety signaling reviews, and data analyses.
• Supervise CSRM medical associates in data analysis and regulatory writing.
• Develop and evaluate department standards, processes, metrics.

Skills

Clinical Development

Clinical Risk Management

Clinical Safety

Pharmacovigilance

Regulatory Documents

Risk Management

Drug Development

Safety Surveillance

Communication & Writing

Education

MD, DO, or equivalent

Board Certification

Job description

Merck & Co. in Rahway, NJ seeks a CSRM Physician to lead pharmacovigilance, risk management and safety surveillance for assigned products, chairing safety teams and guiding regulatory submissions.

You will collaborate with clinical development, epidemiology, regulatory, statistics and manufacturing to ensure robust safety assessments, evaluate safety data from trials, literature and post-approval use, and contribute to Risk Management Plans.