9 дней назад
Global Patient Safety Business Excellence, Senior Manager (Pharmacovigilance)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Global Patient Safety Business Excellence, Senior Manager (Pharmacovigilance): Driving project management, governance, compliance, and operational effectiveness initiatives across Global Patient Safety with an accent on pharmacovigilance, quality systems, and inspection readiness. Focus on leading complex cross-functional programs, strengthening regulatory compliance, managing deviations and CAPAs, and applying automation and analytics to improve business outcomes.
Location: Washington, D.C., District of Columbia, United States
Company
is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead project management and organizational change management standards, methodologies, and continuous improvement across Global Patient Safety.
- Drive governance frameworks, decision-making, and delivery of business-critical initiatives, including enterprise-wide cross-functional programs.
- Provide strategic oversight for pharmacovigilance activities related to mergers, acquisitions, licensing agreements, and divestitures.
- Advance the Global Patient Safety Quality Management System, inspection readiness, audit support, and compliance with global regulatory requirements.
- Develop and report performance and compliance metrics, and facilitate deviations, CAPAs, and quality improvement initiatives.
- Champion automation, analytics, and emerging technologies while building alignment with internal and external stakeholders.
Requirements
- Doctorate degree and 2 years, master's degree and 4 years, bachelor's degree and 6 years, associate's degree and 10 years, or high school diploma/GED and 12 years of safety project management experience.
- Significant experience in pharmacovigilance, drug safety, regulatory affairs, quality, or related life sciences functions.
- Demonstrated expertise in project management, change management, organizational transformation, governance frameworks, and complex enterprise-wide initiatives.
- Ability to interpret pharmacovigilance regulations and compliance requirements, influence senior stakeholders, and work effectively across international, cross-functional environments.
- Strong analytical, facilitation, decision-making, prioritization, and process improvement skills.
- PMP certification or an equivalent change or project management certification is preferred.
Nice to have
- Experience with mergers, acquisitions, and divestitures in life sciences.
- Experience leading fully remote teams across time zones.
- Experience with Lean, Six Sigma, Agile, or similar process improvement methodologies.
Culture & Benefits
- Collaborative, innovative, and science-based work environment focused on serving patients.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time-off plans, work-life balance support, and career development opportunities.
- Flexible work models where applicable to the role.
Hiring process
- Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
- Sponsorship for the role is not guaranteed.
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