DE, GB + 1 moreJob Description Summary
The Senior Director of Global Pharmacovigilance (GPV) provides strategic, operational and people leadership in global product safety risk management at GE Healthcare Pharmaceutical diagnostics. This role is accountable for ensuring effective pharmacovigilance processes, including aggregate reporting and regulatory compliance across multiple regions.The Senior Director leads a team of Drug Safety Scientists and drives the development, standardization, and continuous improvement of PV processes in alignment with FDA, EMA, and ICH requirements. Through cross-functional collaboration with Safety Physicians and external partners, this role supports high-quality safety data, signal detection, and risk management activities.
In addition, the role oversees vendor and resource management, including budget oversight, and supports implementation of PV regulations and procedures. The Senior Director also drives operational performance through metrics, KPIs, CAPA, and process improvements, including the application of LEAN principles.
The Senior Director reports to the Head of Global Drug Safety & Risk Management and contributes to advancing pharmacovigilance processes and global compliance.
Job Description
Primary responsibilities
- Serve as a people leader, develop, manage and mentor a team of Drug Safety Scientists.
- Lead governance and pharmacovigilance strategy of aggregate reporting processes, ensuring compliance with FDA, European Medicine Agency, and International Council for Harmonization requirements across multiple regions.
- Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for Drug Safety & Risk Management.
- Lead vendor and resource management, including vendor selection for Drug Safety & Risk Management activities, financial oversight, invoice approval and budget management, ensuring cost control and operational efficiency.
- Provide strategic leadership for the selection, configuration, validation, and life-cycle management of Drug Safety & Risk Management safety systems and tools, in partnership with IT and Safety Systems (Veeva, PVQ, Smartsheet and PowerBI dashboards).
- Lead interpretation and implementation of PV regulations/legislations. Responsible for keeping Drug Safety & Risk Management procedures in compliance with applicable legislation.
- Collaborate with Safety Physicians and cross-functional teams to ensure high-quality data for aggregate reports, signal detection, Risk Management Plans and risk-benefit assessments.
- Develop and monitor KPIs, CAPA and change control initiatives, strengthening quality and compliance oversight.
- Support hiring and onboarding of new staff for Drug Safety & Risk Management Team.
- Support budget oversight for Drug Safety & Risk Management Team
- Embrace LEAN methodologies (Establish and monitor operational metrics, dashboards, and performance indicators to support data-driven decision making.
- Perform other duties related to the position as necessary and as defined in SOPs and/or at the request of supervisor.
- Only candidates in EST or CST time zones will be considered at this time.
Required Qualifications
- Healthcare Professional (RN/BSN, PharmD, MD, etc.), Degree in Life Sciences, Biology, Business, Analytics
- Minimum of 10 years of pharmaceutical/biotechnology PV experience, with substantial global PV leadership (people + vendor + systems)
- Ability to lead and mentor a team
- Experience in leading cross-functional safety activities, driving process optimization, automation and inspection readiness initiatives and leading strategic innovations.
- Expert knowledge of FDA and EU legislation and ICH PV Guidelines and knowledgeable use of MedDRA are required.
- Strong operational and project management skills; ability to manage multiple deliverables under tight timelines and ability to manage global projects.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
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