BeOne Medicines USA, Inc. seeks Associate Director, Safety Reporting in Cambridge, MA:
**Job Duties** **:** Support and manage the proper function, maintenance, and validation of data & analytics solutions (business intelligence, automation) and adherence to BeOne Medicines policies and applicable global (PV) regulations. Manage changes to the data & analytics solutions (business intelligence, automation) under the BeOne Medicines 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. 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 and assist in the development of SOPs for the safety system & its maintenance. **_Telecommuting is an option._**
**Minimum Requirements** **:** Master's degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or a related quantitative discipline, and 5 years of experience in the job offered or in any occupation in related field, OR Bachelor's degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or a related quantitative discipline, and 7 years of progressively responsible experience in the job offered or in any occupation in related field.
**Special Skill Requirements** **:** (1) Pharmacovigilance Systems (Argus Safety or any other Drug Safety Databases); (2) Writing Advanced SQL queries and developing reports using BI Reporting Tools; (3) Aggregate Safety Reports and management of inspection-related requests; (4) SDLC Process and regulatory requirements related to GxP System implementations. Any suitable combination of education, training and/or experience is acceptable. **_Telecommuting is an option._**
Disregard the below range, the selected candidate will earn a wage of $162,400 -$203,000 per annum.
Submit resume with references to: Req.#: L24-150319 at: ATTN: Amy Nobriga,
[email protected].
\#LI-DNI
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.