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.
Let us know
Help us maintain the quality of jobs posted on RemoteTechJobs and let us know if:
About Us:We help businesses transform by providing them with one unified cloud-based solution to run their entire organization. Our company headquartered in South Florida is a full-service Oracle NetSuite Partner which engages in consulting, implementation,.
About UsRisingWave Labs is a series-A start-up that innovates next-generation database systems. The company develops RisingWave (https://github.com/risingwavelabs/risingwave), a cloud-native SQL streaming database for modern real-time applications.RisingWave.
Overview:As an Associate Data Engineer, you will be working with a team of technologists to deliver insight across various aspects of CareCentrix Master Data Management system. You will be working on developing and managing database frameworks to ensure.
Overview:We are CONNECTING HEALTH AND WEALTH. Come be part of remarkable.How you can make a differenceWe are looking for a driven Enterprise Data Analyst to join our team. This person will be responsible for helping ensure our critical data import and.
THE OPPORTUNITY:We are seeking a talented Snowflake Database Engineer - Cloud who designs, develops, tests and maintains database solutions on the Cloud. Data Engineer will be responsible for implementing large scale data intelligence solutions around.
OPENTEXT - THE INFORMATION COMPANYAs the Information Company, our mission at OpenText is to create software solutions and deliver services that redefine the future of digital. Be part of a winning team that leads the way in Enterprise Information Management..
Kellogg Garden Products a stable, steadfast family-owned business has an immediate need for a Power BI/Report Writer engineer.Established in 1925 and despite steady growth, we remain guided by the core values of our founder, H. Clay Kellogg: integrity,.
About the Position: We are seeking a Data Analyst who will support the business by delivering analytics solutions and generating operational insights from a variety of data sources. You will be responsible for knowing the company’s data properly to answer.
Please note, this role is not able to offer visa transfer or sponsorship now or in the futureThis is a remote position open to any qualified applicant in the United States.We are Cognizant Artificial IntelligenceDigital technologies, including analytics.
The Data Migration Specialist supports Product Safety through all phases of Project Aurora. The successful candidate will possess the ability to evaluate varied AS IS Product Safety Environmental Health and Safety Specifications against data standards.
More jobs by this company
Job DescriptionAbout this roleAs Biogen’s Service Delivery Manager (SDM) key responsibilities will be to make sure that technical service delivery and support processes by our vendor partners and managed service providers consistently deliver an elevated.