Associate Director, PV Business Process Office-Periodic Safety Deliverables

Employer
AbbVie
Location
Lake County, IL, US
Posted
Oct 16, 2019
Ref
1906817
Required Education
Bachelors Degree
Position Type
Full time
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.‚Äč

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 partners to gain alignment of people, process and technology. They 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.

Looking for a high performing, high impact individual to oversee the Periodic Safety Reporting safety deliverables processes. A highly cross-functional team of medical and scientific guides. They collaborate on creating, publishing and submitting to regulatory agencies globally a document that describes the aggregate review of the safety profile of a particular product.

Responsibilities:

  • Establishes process strategy, objectives and long-range roadmap with input from key partners (including business and IT); identifies, facilitates/implements process changes
  • Monitors and reports process performance against critical metrics and process health vs. plans. Designs / oversees Performance Measurement/Management Plan.
  • Gains in-depth understanding of a process, how the SMEs work within the process, process strengths and weaknesses, individual frustrations, etc. Is a guide in the processes and will be called as a process guide during inspections.
  • Engages partners across the process including, process workers (SMEs), business owners, leadership and IT to ensure alignment on process and resource priorities; validates the merit and applicability of initiatives across functions
  • Forms positive relationship with BO and aligns with them on key process and systems decisions, including the prioritization of initiatives
  • Synchronizes process and system improvement plans with other process owners; prioritizes work across processes
  • Primary point of contact for process and system related decisions; represents end-to-end process(es) in key meetings (eg RAP Team, APMO, APMB, etc.) and with external partners
  • Actively gathers external benchmarking and standard methodologies as input to process decisions; maintains active knowledge and awareness of all associated regulations
  • Maintains regular process health checks, as well as checks to review the impact of new implementations
  • Maintains high-level understanding of U.S. and international safety regulations and current regulatory safety review processes.


Basics:

  • Bachelor's degree, masters preferred
  • 6 years process management experience required
  • LSS/LEAN certification desired
  • Positive relationship management skills, Emotional Intelligence and communicative skills required