AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.?
The Pharmacovigilance (PV) Business Process Office is comprised of Business Process Owners (BPO’s) who are accountable for the definition, health, and performance of PV’s key end-to-end processes. The BPO partners closely with various process stakeholders to ensure alignment of people, process and technology and are responsible for the performance of PV’s key end-to-end processes in realizing their objectives as measured by process indicators and are empowered to identify and champion improvements.
Our team is looking for a high performing, high impact individual to oversee the Periodic Safety Reporting safety deliverables processes. (i.e. Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR)...). A highly cross-functional team of medical and scientific experts collaborate on creating, publishing and submitting to regulatory agencies around the world, a document that describes the aggregate review of the safety profile of a particular product.
Accountable for oversight and process-related decision-making associated with the global implementation of assigned end-to-end processes.
Strategic management of process performance and reporting routines with a highly cross-functional group of process partners
Documentation of end-to-end process requirements and supporting practices and methods
Monitor and report process performance against performance measures and specification limits
Establish the process strategy, strategic objectives and gap-closing roadmap
Identify, define, and prioritize process improvement opportunities
Oversee investigations and Action Plans from inspection findings, audit observations and internally identified non-conformities
Perform periodic process health checks and run remediation plans
Maintain awareness of all relevant regulations and monitoring changes in regulatory intelligence
Actively gathers external benchmarking and standard methodologies as input to process decisions
Level of the position will be based upon the candidate's experience.
Bachelor of Science degree required
Advanced degree in a medical, science or engineering curriculum desired
Masters of Business Administration (MBA) preferred
Lean Six Sigma and/or Lean certification required
10 years process management and/or continuous improvement experience required
Previous experience as a Process Owner and/or Value Stream Manager preferred
Internal Number: 1906720
About AbbVie Inc.
At AbbVie, we have the expertise of a proven pharmaceutical leader and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today – a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people and societies around the globe.