General Description:
This role is responsible for the ongoing management and support for the safety reporting, business intelligence, and analytics capabilities. The individual will provide technical expertise, support, and guidance to the BeiGene Global Product Safety organization to facilitate the aggregate safety report production, ongoing safety analyses, signal detection. In addition, this individual will respond to time-sensitive requests from internal and external stakeholders such as Drug Safety/PV Scientists, Clinical Science, Clinical Operations, Regulatory Authorities, and Business partner ad hoc requests.
Essential Functions of the Job:
Support and manage the proper function, maintenance, and validation of data & analytics solutions (business intelligence, automation) and adherence to BeiGene policies and applicable global (PV) regulations.
Manage changes to the data & analytics solutions (business intelligence, automation) under the BeiGene change control policy, including configuration changes and system upgrades.
Manage the development and validation of required aggregate safety reports.
Contribute to ad hoc report specification, development, validation & implementation and maintain required validation documents.
Manage timely flow of business intelligence information to users.
Act as a training resource to departmental staff on the use of reporting solutions and Safety Systems.
Work as a team member to achieve goals by communicating information and project status; collaborating on problem resolution; demonstrating leadership and providing technical expertise.
Serve in a consultative role within or outside of the department to resolve issues pertaining to the safety system and interface with other PV tools.
Assist in the development of SOPs for the safety system & its maintenance.
Participates in the implementation of additional Safety informatics systems including Safety Data mart, signal detection and surveillance tools, and reporting systems.
Assist with internal and external audits of the Safety System.
Education Required:
Bachelor’s degree in computer science or related fieldQualifications:
BS degree with 7 plus years of overall experience with with at least 5 plus years of IT, Data Analytics or Drug Safety Systems/Reporting support experience.
Strong interpersonal and presentation skills, including the ability to liaise with senior leaders.
Excellent oral and written communication.
Ability to deal with ambiguity and make decisions within a high-growth, rapidly evolving environment.
Computer Skills:
Knowledge of Argus Safety Database strongly preferred.
Ability to write advanced SQL code and build reports in reporting tools.
Proficiency with standard desk-top computing programs (i.e., Microsoft Word, Microsoft Excel, Microsoft Power-Point, and Microsoft Access) is required
Ability to support and suggest workspace repository solutions for secure, confidential PV data & documents (e.g., sFTP servers, secure PV SharePoint sites)
Travel:
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.