Senior Manager, GPS Programs & Digital Assets

Role Summary

Senior Manager, GPS Programs & Digital Assets. BeOne seeks experienced professionals who are motivated, collaborative, and committed to fighting cancer. This role oversees BeOne’s Post Marketing Organized Data Collection Program (PMODCP) and sponsored digital asset/social media programs to ensure pharmacovigilance activities are efficient, compliant, and high-quality.

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, especially data collection tool reviews, to estimate potential safety information and ensure PV requirements are included.
• Serve as liaison for GPS and business owners 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 Partners.
• Send program notifications regarding new programs, changes, and terminations to stakeholders for PV initiation and implementation.
• Support training for contract partners for the Programs.
• Coordinate day-to-day PV activities for the programs and provide PV operation support as needed.
• Collaborate with GPS to align case intake, submission, reconciliation training, and other PV activities.
• Conduct and coordinate PV close-out activities when programs are completed.
• Maintain a tracker for the Programs.
• Support the PSMF update by providing Program information to the PSMF team.
• Work cross-functionally with Quality Assurance on inspection and audit matters regarding the Programs.
• Participate in developing and maintaining PV policies, SOPs, and guidance documents to ensure compliance with regulatory requirements and best practices.
• Identify opportunities to improve and optimize current processes.
• Escalate issues to GPS management as needed.

Qualifications

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

Skills

• Proficient in Word, Excel, and PowerPoint.

Education

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

Additional Requirements

• Travel: 0-10%