Associate Director, Safety Reporting

BeiGene•Cambridge, MA

1d•$162,400 - $203,000•Remote

About The Position

BeOne Medicines USA, Inc. seeks an Associate Director, Safety Reporting in Cambridge, MA. This role involves supporting and managing data & analytics solutions (business intelligence, automation) for pharmacovigilance, ensuring adherence to company policies and global regulations. The position includes managing changes to these solutions, developing and validating aggregate safety reports, contributing to ad hoc reports, and ensuring the timely flow of business intelligence information. The Associate Director will also act as a training resource, collaborate with team members, and serve in a consultative role for safety system issues. Participation in the implementation of additional Safety informatics systems, assistance with audits, and SOP development are also key responsibilities. Telecommuting is an option.

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.
Pharmacovigilance Systems (Argus Safety or any other Drug Safety Databases)
Writing Advanced SQL queries and developing reports using BI Reporting Tools
Aggregate Safety Reports and management of inspection-related requests
SDLC Process and regulatory requirements related to GxP System implementations.

Responsibilities

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.