Senior Principal Scientist, PV & Risk Governance

Merck & Co.; Rahway (NJ); Hybrid; USD 210,000 - 331,000; Full time

Benefits offered by this job

Medical benefits

401(k) retirement plan

Paid holidays

Job summary

Merck & Co. is seeking a senior CSRM process owner responsible for end-to-end safety process governance, SOP development, and execution oversight.

The role requires deep pharmacovigilance expertise, leadership in risk management, and collaboration with regulatory bodies to ensure compliant, effective processes across divisions. The incumbent will drive metrics, oversee training, and coordinate with CSRM leadership, IPV, and QPPV to address global and local considerations.

Qualifications

• Master's degree in nursing, PharmD, PA or other relevant clinical health related field preferred.
• 10-12 years of professional experience with both clinical and pharmaceutical industry experience, including safety experience.

Responsibilities

• Owns end-to-end CSRM processes, SOP development, and governance across departments.
• Evaluate regulatory changes and integrate them into processes.
• Monitor metrics, compliance, and identify process improvements.
• Serve as single point of contact for internal/external stakeholders on assigned processes.
• Provide expert consultation on pharmacovigilance, risk management, and regulatory interactions.
• Educate stakeholders on responsibilities and coordinate cross-divisional communication.
• Lead engagement with auditors, inspectors, and regulators as needed.
• Develop strategies for regulatory documents and responses to safety inquiries.

Skills

Pharmacovigilance

Risk management

Regulatory compliance

Stakeholder management

Training development

Education

Master's degree in nursing, PharmD, PA or related field

Job description

Merck & Co. is seeking a senior CSRM process owner responsible for end-to-end safety process governance, SOP development, and execution oversight.

The role requires deep pharmacovigilance expertise, leadership in risk management, and collaboration with regulatory bodies to ensure compliant, effective processes across divisions. The incumbent will drive metrics, oversee training, and coordinate with CSRM leadership, IPV, and QPPV to address global and local considerations.