Senior Principal Scientist, Pharmacovigilance & Safety

1000 Merck Sharp & Dohme LLC; Rahway (NJ); Sur place; USD 282 000 - 444 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision

401(k) retirement benefit

Paid holidays and vacation

Résumé du poste

Merck & Co., Inc. in Rahway, NJ seeks a CSRM Physician to lead pharmacovigilance and risk management for investigational and marketed products.

You will chair the Risk Management Safety Team and direct safety plans across product life cycles. This role collaborates with clinical development, regulatory, epidemiology, and manufacturing to ensure robust safety assessment and high-quality regulatory documents.

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

Responsabilités

• Engage in product development activities via membership on Product Development Teams and chairing Risk Management and Safety Team
• Collaborate with clinical development to ensure safety assessment supports development programs
• Work with cross-functional teams to align safety topics with global pharmacovigilance strategies
• Evaluate safety data from trials, literature, and post‑marketing use
• Contribute to safety documentation such as CTD components and Risk Management Plans
• Oversee safety surveillance activities and risk minimization strategies
• Lead labeling reviews and management of safety sections in company documents
• Prepare safety analyses for regulatory filings and supervise medical associates

Connaissances

Clinical Development

Clinical Risk Management

Clinical Safety

Clinical Training

Drug Development

Drug Safety Surveillance

Pharmacovigilance

Regulatory Documents

Risk Management

Safety Assessment Reports

Formation

MD, DO, or equivalent

Description du poste

Merck & Co., Inc. in Rahway, NJ seeks a CSRM Physician to lead pharmacovigilance and risk management for investigational and marketed products.

You will chair the Risk Management Safety Team and direct safety plans across product life cycles. This role collaborates with clinical development, regulatory, epidemiology, and manufacturing to ensure robust safety assessment and high-quality regulatory documents.