Senior Manager, GPS Programs & Digital Assets

Role Summary

Senior Manager, GPS Programs & Digital Assets. BeOne is seeking an experienced professional to oversee pharmacovigilance activities for Post Marketing Organized Data Collection Programs and digital asset/social media programs, ensuring compliance and high-quality standards. Collaboration with multiple internal and external stakeholders is required.

Responsibilities

• Create and maintain the overview of BeOne Programs such as Patient Support Programs, Market Research programs, Expended Access Programs, and company websites or social media platforms for PV purposes.
• Collect detailed Program information from Business Owners
• Conduct program design reviews, especially data collection tool reviews, to assess safety information opportunities and ensure PV requirements are included in program design and documents
• Serve as liaison for GPS and business owners for programs and facilitate necessary discussions
• Provide guidance and support to Program teams for PV matters
• Support Business Owners functions (Medical Affairs, Commercial, Marketing) in developing processes, forms, and training for the Programs
• Support review of contracts with third parties for the Programs
• Generate Program Identification Numbers and notify GPS functions, Business Owners, and Business Partners
• Notify stakeholders of new programs, changes, and terminations for PV activities initiation and implementation
• Support training of contract partners for the Programs
• Coordinate day-to-day PV activities for the programs and provide PV operation support as needed
• Collaborate with GPS functions to align among case intake, submission, reconciliation training, and other PV activities
• Conduct and coordinate PV close-up activities when each program is completed
• Maintain a tracker for the Programs
• Support PSMF updates by providing Program information to the PSMF team in an agreed format
• Work cross-functionally with Quality Assurance for inspection and audit matters regarding the Programs
• Participate in developing and maintaining PV policies, SOPs, and guidance documents to ensure regulatory compliance
• Look for opportunities to improve and optimize current 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 and other 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; capable of multi-project work
• Problem-solving skills with urgency, attention to detail, and ability to execute under time/resource pressure

Skills

• Proficient in Word, Excel, and PowerPoint

Education

• 7+ years of experience with a Bachelor's/Advanced degree in life sciences, nursing, pharmacy or related healthcare field (e.g., RN, PharmD, NP, PhD, MPH)

Additional Requirements

• Travel: 0-10%