Senior Manager, GPS Programs & Digital Assets

Role Summary

Senior Manager, GPS Programs & Digital Assets. BeOne continues to grow with opportunities for experienced professionals who are motivated, collaborative, and focused on fighting cancer. This role oversees pharmacovigilance-related programs and digital assets to ensure compliant, efficient operations across programs.

Responsibilities

• Create and maintain the overview of BeOne Programs, including Patient Support Programs, Market Research programs, Expanded Access Programs, company websites or social media platforms for PV purposes.
• Collect detailed Program information from Business Owners.
• Conduct program design reviews to estimate safety information collection and ensure PV requirements are included.
• Serve as liaison for GPS and program stakeholders; facilitate discussions.
• Provide guidance and support to Program teams on PV matters.
• Support Business Owners in developing processes, forms, and training for Programs.
• Review contracts with third parties for Programs.
• Generate Program Identification Numbers and notify relevant parties.
• Notify stakeholders of new, changed, or terminated programs for PV initiation and implementation.
• Facilitate training to contract partners for Programs.
• Coordinate day-to-day PV activities for Programs and provide PV operation support as needed.
• Collaborate with GPS functions to align case intake, submission, reconciliation, training, and PV activities.
• Coordinate PV close-up activities at program completion.
• Maintain a tracker for Programs.
• Support PSMF updates by providing Program information to the PSMF team.
• Work with Quality Assurance on inspections and audits regarding Programs.
• Participate in developing and maintaining PV policies, SOPs, and guidance documents for compliance with regulatory requirements and best practices.
• Identify opportunities to improve and optimize processes.
• Escalate issues to GPS management as needed.

Qualifications

• 7+ years of medical/scientific experience, including direct pharmacovigilance.
• Knowledge of GCPs, ICH guidelines, and FDA/EMA/international regulations.
• Experience onboarding, overseeing, and managing business partners.
• Strong interpersonal and communication skills; proactive; able to work independently and in a team.
• Detail-oriented with strong organizational, prioritization, and time management skills; able to handle multiple projects.
• Demonstrated problem-solving ability, sense of urgency, attention to detail, and ability to operate under time/resource pressures.

Skills

• Proficient in Word, Excel, and PowerPoint.

Education

• 7+ years' experience with a Bachelor's or advanced degree in life science, nursing, pharmacy, or related healthcare field (RN, PharmD, NP, PhD, MPH, etc.).

Additional Requirements

• Travel: 0-10%