The Principal, PV/Drug 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.
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