1 день назад
Manager, GPV Compliance & Business Management
121 103 - 181 125$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, GPV Compliance & Business Management (Pharmacovigilance Compliance): Coordinating global pharmacovigilance compliance and contract management activities with an accent on audit readiness, vendor oversight, CAPA and deviation processes, and compliance metrics. Focus on maintaining PV systems and procedural documentation, managing safety-related contract assessments, supporting inspections, and enabling process improvements through technology and AI tools.
Location: Princeton, New Jersey, United States
Salary: $121,103–$181,125 annually, plus incentive opportunity.
Company
Pharmaceutical Companies supports pharmaceutical development, commercialization, and pharmacovigilance operations.
What you will do
- Manage assigned global pharmacovigilance compliance and business management activities.
- Review global contracts for safety-relatedness and maintain accurate entries in the OCT system.
- Coordinate with Finance, Procurement, Vendor Management, Legal, affiliates, and global pharmacovigilance teams.
- Maintain PV vendor qualification records, the qualified vendor list, procedural documents, clause templates, and PSMF Annex B3.
- Monitor and present contract compliance metrics and support audits, inspections, CAPA activities, and corrective actions.
- Contribute to process improvements and technology enablement, including AI tool development and implementation.
Requirements
- Bachelor’s degree.
- At least 2 years of pharmacovigilance compliance or quality management experience in the pharmaceutical industry, or relevant leadership experience.
- Knowledge of ICH, US, and EU pharmacovigilance regulations and requirements.
- Experience in a global setting, vendor relationship management, and vendor oversight.
- Experience coordinating or participating in pharmacovigilance audits in the pharmaceutical industry.
- Strong project management, communication, presentation, computer, Microsoft Word, Excel, PowerPoint, and Outlook skills.
Culture & Benefits
- Comprehensive medical, dental, vision, and prescription drug coverage.
- Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
- Tuition reimbursement and student loan assistance.
- Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
- Work includes global and regional collaboration, meetings, travel as applicable, and matrix-based cooperation.
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