The Principal, Pharmacovigilance (PV) Drug Data Safety Insights is viewed as a leader within the area of safety systems and will support the reporting needs for the Global Safety and Regulatory Sciences (GSRS) department. The Principal will also be a key member of project teams, utilizing technical skills to help define and build solutions. This role will be a primary liaison between business users and software vendors and internal IT departments.

What You'll Do

• Produce outputs to support the preparation of various aggregate safety reports including PADER, PSURs and DSURs
• Generate ah-hoc reports and line listings using Business Objects
• Provide end-to-end support and maintenance of the Global Safety System
• Working with the TADI team, define technical strategy to support regulatory commitments and operational efficiency including safety analyses and signaling, and operational metrics identification and implementation
• Understand and communicate business requirements, issues and subsequent resolution
• Leads or consults on process improvement initiatives and strategic projects including new system implementation and upgrades
• Modify processes, conventions and standards based on the changing requirements, tools, or resource models
• Train and mentor junior team members
• Contribute to software selection and vendor evaluation
• Responsible for bridging the gap between technical and non-technical staff as new technologies are introduced
• Represent Biogen and GSRS at Industry/vendor forums

• Bachelor's degree in relevant field, advanced degree preferred
• 8+ years working in Drug Safety/Pharmacovigilance (PV), supporting safety systems and/or business process/operations
• Working knowledge of current global drug safety regulations
• Experience with the implementation, data migration, validation, maintenance, upgrade of Safety Systems (ARISg, LSMV, ARGUS, Veeva etc.,)
• Experience providing oversight to PV vendors and hosting partners
• 7+ years of experience in relational database management systems including Oracle, MS-SQL and/or PostgreSQL
• Proficient in writing complex SQL code and creating reports in Business Objects

All your information will be kept confidential according to EEO guidelines.

The base compensation range for this role is $116,500 to $187,800. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.