Senior Principal Scientist, Pharmacovigilance & Risk

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

Job summary

Merck & Co. in North Wales, PA seeks a highly experienced CSRM safety professional to own end-to-end pharmacovigilance processes. You will oversee SOPs, metrics, and cross-functional governance, and provide expert consultation on PV and risk management to global teams.

Responsibilities include developing RMPs/REMS strategies, coordinating with regulators and auditors, and leading training initiatives while ensuring compliance with health authority expectations and company policies.

Qualifications

• Master's degree in nursing, PharmD, PA or other relevant clinical health related field preferred.
• ≥5 years of safety experience (PV or clinical) with direct PV process involvement.
• Ability to translate regulatory requirements into practical guidance.
• Strong written and verbal communication, facilitation and stakeholder management.

Responsibilities

• Own end-to-end CSRM processes, SOPs, and resources with cross-functional engagement.
• Evaluate regulations and integrate changes to maintain compliant processes.
• Monitor metrics, support continuous process improvement, and governance.
• Serve as contact for key stakeholders, coordinating mitigation plans with leadership.
• Provide expert consultation on pharmacovigilance, risk management, and health authority interactions.
• Educate stakeholders on responsibilities and oversee training delivery.
• Serve as process expert in audits, inspections, and regulator interactions.
• Develop strategies for regulatory documents and responses to safety inquiries.
• Collaborate with IPV and QPPV to align local/global processes and considerations.

Skills

Pharmacovigilance

Risk management

Process governance

Stakeholder management

Regulatory compliance

Cross-functional teamwork

Training delivery

Education

Master's degree in clinical health related field

Job description

Merck & Co. in North Wales, PA seeks a highly experienced CSRM safety professional to own end-to-end pharmacovigilance processes. You will oversee SOPs, metrics, and cross-functional governance, and provide expert consultation on PV and risk management to global teams.

Responsibilities include developing RMPs/REMS strategies, coordinating with regulators and auditors, and leading training initiatives while ensuring compliance with health authority expectations and company policies.