Manager of Service Operations at Mindray North America, leading customer - focused service processes. Overseeing service workflows and team performance within a healthcare technology environment.
About the role
- Director of Pharmacovigilance Operations at Amgen acting as primary contact for safety reporting and managing compliance. Leading teams on adverse event management and process improvements.
Responsibilities
- Act as the US/EU Local Safety Officer and primary FDA/EMA contact for safety reporting, overseeing all adverse event intake, case processing, and submissions for the Rare Disease portfolio.
- Ensure compliance with global pharmacovigilance (PV) regulations, manage vendor oversight, and drive continuous process improvement across safety operations.
- Oversee adverse event case intake, processing, and reporting to FDA/EMA, business partners, license partners and vendors.
- Serve as Business Process Owner for adverse event (AE) Intake, ensuring compliance, training, and process control.
- Ensure vendor adherence to approved procedures and performance standards; monitor quality and compliance metrics.
- Act as liaison between Global Patient Safety, clinical teams, and business partners to ensure complete and accurate AE data capture.
- Support inspection readiness, audits, and CAPA follow-up; serve as point of contact for regulatory inspections.
- Lead electronic serious adverse events (eSAE) governance and contribute to process improvement and implementation of new safety systems and standards.
- Develop and maintain SOPs, training materials, and safety documentation in compliance with global PV requirements.
- Foster cross-functional communication and collaboration across Global Safety, Clinical Operations, and external partners.
Requirements
- Degree educated.
- Demonstrated experience in pharmacovigilance drug safety/life sciences industry.
- Proven record of leading and managing teams, ideally with global or cross-regional scope.
- Strong decision-making and strategic capabilities, with experience building and sustaining effective cross-functional partnerships and communication channels.
Benefits
- Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
TS
Manager providing strategic direction for welfare and self - reliance employment services. Overseeing global operations and developing training strategies for international areas.
Intern working on portfolio management and property operations at Digital Realty. Gaining experience in the data center industry while pursuing a Bachelor's or Master's degree.
Senior Services Operations Manager overseeing operations for Ricoh's Global and Vertical customers in North America. Responsible for P&L, customer relationships, and implementing operational best practices.
Junior Operations Consultant supporting benefits administration at Evertec, a financial technology company in Brazil. Responsible for administrative tasks related to retirement and BPO regulations.
Ambulatory Operations Analyst at UW Health in Rockford, IL analyzing operations for improved efficiency. Collaborating with teams and generating reports to support operational goals.
Senior Logistics Operations Manager responsible for operational performance across Milan, Bologna, and Rome. Leading teams, managing P&L, and ensuring service quality for key clients.
Gestor de Operações de Logística responsável pela operação de logística em Portugal. Envolvendo recrutamento, gestão de motoristas, e implementação de processos operacionais.
Trademark Operations Supervisor responsible for day - to - day operational functions and team leadership at Fenwick & West. Overseeing trademark support staff and ensuring efficient workflows across the trademark practice.
Agent Title Operations facilitating Title Services requests within Title Transfer & Resale sector at Hilton Grand Vacations. Coordinating, preparing, and managing documentation and customer service in a fast - paced environment.