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General Description:

This position is responsible for creating and maintaining the oversight of BeiGene’s Post Marketing Organized Data Collection Program (PMODCP) and BeiGene sponsored digital asset/ social media programs (hereinafter collectively referred as “Programs” below) to ensure all pharmacovigilance activities required in such Programs are performed in an efficient, consistent and compliant manner. The position requires an experienced and confident manager who can collaborate with multiple stakeholders internally and externally ensure compliance and high-quality standards.

Essential Functions of the Job:

+ Create and maintain the overview of BeOne Programs, such as Patient Support Programs, Market Research programs, Expended Access Programs, company websites or social media platforms for PV purposes.

+ Collect detailed Program information from Business Owners

+ Conduct the program design review, especially the data collection tool review to be used in the Programs to estimate the possibility of receiving safety information and to ensure PV requirements are included in the Program design and documents

+ Serve as liaison for GPS and business owners for programs and facilitate necessary discussion

+ Provide guidance and support to Program teams for PV matters

+ Support Business Owners functions, such as Medical Affairs, Commercial, or Marketing in the development of processes, forms, and/or training for the Programs

+ Support review of the contracts with third parties for the Programs

+ Generate Program Identification Number for each Program and notify the assigned Program Identification Number to GPS functions, Business owners and Business Partners

+ Send Program notification regarding new program, change of program and termination of programs to stakeholders for PV activities initiation and implementation

+ Support facilitating training to contract partners for the Programs

+ Responsible for coordination of day-to-day PV activities for the programs, provide PV operation support if necessary

+ Collaborate with GPS functions to ensure alignment among case intake, submission, reconciliation training and any other PV activities

+ Conduct and coordinate PV close-up activities when each program is completed

+ Responsible for maintaining a tracker for the Programs

+ Support PSMF update by providing Program information to PSMF team in an agreed format

+ Work cross functionally with Quality Assurance functions for inspection and audit matters regarding the Programs.

+ Participate in the development and maintenance of PV policies, SOP and guidance documents for the Programs to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices

+ Look for opportunities to improve and optimize the current processes

+ Escalate issues to GPS management as needed

Supervisory Responsibilities:

N/A

Computer Skills:

+ Proficient in standard computer software (Word, Excel and Power point presentations)

Other Qualifications:

+ 7+ years of medical, scientific, including direct pharmacovigilance experience

+ Knowledge of GCPs, ICH guidelines and FDA, EMA, and other international regulations and guidelines

+ Experience with onboarding, overseeing and managing business partners

+ Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment

+ Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously

+ Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.

Education Required:

7+ years' experience with Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (RN, PharmD, NP, PhD, MPH, etc.)

**Travel:** 0-10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.