Lead Pharmacovigilance & Safety Strategy Scientist

Regulatory Jobs; Pennsylvania; Vor Ort; USD 210.000 - 331.000; Vollzeit

Benefits dieser Stelle

Health, dental, vision insurance

401(k) and paid holidays

Zusammenfassung

Merck & Co., Inc. in USA—Pennsylvania seeks a senior CSRM process owner with extensive pharmacovigilance and risk management experience.

You will oversee the CSRM safety processes, develop and monitor metrics, ensure cross-functional engagement, and provide expert consultation on regulatory safety issues. The role includes interaction with health authorities, process governance, and development of mitigation plans.

Qualifikationen

• Master’s degree in nursing, PharmD, PA or other relevant clinical health related field preferred.
• 10–12 years of professional experience with clinical and pharmaceutical industry background.
• Demonstrated expertise in pharmacovigilance and risk management processes.

Aufgaben

• End-to-end process ownership including SOPs and execution resources for assigned processes.
• Evaluate emerging regulations and coordinate changes with SOP owners.
• Develop and monitor metrics, compliance monitoring, and opportunities for process improvement.
• Consult CSRM teams on pharmacovigilance and risk management including health authority interactions.
• Lead engagement with auditors, inspectors, and regulators on behalf of the company.

Kenntnisse

Pharmacovigilance

Risk management

Regulatory compliance

Stakeholder engagement

Process governance

Ausbildung

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

Jobbeschreibung

Merck & Co., Inc. in USA—Pennsylvania seeks a senior CSRM process owner with extensive pharmacovigilance and risk management experience.

You will oversee the CSRM safety processes, develop and monitor metrics, ensure cross-functional engagement, and provide expert consultation on regulatory safety issues. The role includes interaction with health authorities, process governance, and development of mitigation plans.