Senior Principal Scientist, Pharmacovigilance & Risk – Hybrid

Merck; Rahway (NJ); Híbrido; USD 210.000 - 331.000; Tempo integral

Benefícios oferecidos por esta vaga

Annual bonus

Long-term incentive

Comprehensive benefits

Resumo da vaga

Merck & Co., Inc. in Rahway, NJ seeks an experienced CSRM process owner to oversee end-to-end pharmacovigilance and risk management activities across cross-functional teams.

You will lead development of SOPs, monitor compliance, and drive continuous improvement with senior CSRM leadership. You will provide expert consultation on pharmacovigilance, coordinate with regulatory stakeholders, and mentor teams in ADRs, REMS, and related safety activities, including risk minimization strategies and

Qualificações

• 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 required, including at least 5 years in safety (PV or clinical).
• Demonstrated expertise in pharmacovigilance and risk management processes; ability to translate regulatory requirements into guidance.

Responsabilidades

• Oversee development and maintenance of departmental SOPs and execution resources for assigned processes; ensure cross-functional engagement.
• Evaluate emerging regulations and coordinate changes with SOP owners to support compliant end-to-end processes.
• Lead continuous process evaluation, metrics collection, compliance monitoring, and ongoing improvement.
• Serve as single point of contact for assigned processes and coordinate with CSRM leadership on risk mitigation.

Conhecimentos

Adverse Event Report

Clinical Judgment

Cross-Functional Teamwork

Detail-Oriented

Drug Safety Surveillance

Global Program Development

Pharmacovigilance

Regulatory Compliance Audits

Risk Management

Safety Databases

Formação

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

Descrição da vaga

Merck & Co., Inc. in Rahway, NJ seeks an experienced CSRM process owner to oversee end-to-end pharmacovigilance and risk management activities across cross-functional teams.

You will lead development of SOPs, monitor compliance, and drive continuous improvement with senior CSRM leadership. You will provide expert consultation on pharmacovigilance, coordinate with regulatory stakeholders, and mentor teams in ADRs, REMS, and related safety activities, including risk minimization strategies and