Senior Principal Scientist, Pharmacovigilance & Risk

Merck; North Wales (Montgomery County); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck & Co., Inc. in North Wales, PA seeks a CSRM Safety Science role owner to manage end-to-end safety processes, SOPs, and risk management plans for assigned programs. You will lead cross-functional teams, drive regulatory compliance, and provide expert PV guidance to internal and external stakeholders.

The position requires deep PV knowledge, metrics oversight, and collaboration with CSRM leadership to deliver process improvements, training, and regulatory submissions.

Qualifications

• 10-12 years of professional experience in clinical and pharmaceutical industry with safety PV exposure
• Strong expertise in pharmacovigilance and risk management processes
• Excellent written and verbal communication and stakeholder management skills
• Experience in governance, compliance monitoring, metrics interpretation and training development

Responsibilities

• Oversee development and maintenance of departmental SOPs and execution resources with cross-functional engagement
• Lead regulatory changes and integrate updates with SOP owners and stakeholders
• Monitor metrics, compliance, and identify opportunities for process improvement
• Serve as single point of contact for CSRM processes for internal/external stakeholders
• Provide expert consult on pharmacovigilance, risk management, and health authority interactions
• Educate stakeholders on responsibilities and coordinate cross-divisional training
• Engage with auditors, inspectors, regulators on behalf of the company
• Develop strategies for regulatory documents and responses to safety inquiries
• Support IPV with local regulatory considerations and global alignment
• Coordinate PSMF content and QPPV oversight; interface with QPPV office

Skills

Pharmacovigilance

Risk management

Cross-functional teamwork

Regulatory compliance

Communication

Education

Master's degree in nursing/PharmD/PA or clinical health field

Job description

Merck & Co., Inc. in North Wales, PA seeks a CSRM Safety Science role owner to manage end-to-end safety processes, SOPs, and risk management plans for assigned programs. You will lead cross-functional teams, drive regulatory compliance, and provide expert PV guidance to internal and external stakeholders.

The position requires deep PV knowledge, metrics oversight, and collaboration with CSRM leadership to deliver process improvements, training, and regulatory submissions.