Senior Manager, Strategy Mangement Office- PV Partnership Management - Illinois, United States,

This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) organization's Global PV Strategy Management Office. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.

The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the product lifecycle. The team partners with stakeholders across the product lifecycle to provide innovative safety-driven strategies, which will maximize product benefit-risk for patients. The Office of the PST plays a critical role in shaping and driving the priorities of the PST by providing strategic and operational leadership oversight of the PST model.

As a Senior Manager, PV Partnership Management within the Office of the PST, you are in a highly visibility role that provides various opportunities to influence and drive operational excellence by enhancing processes, technology and automation across the Office of the PST.

  • Proactively identifies and leads process, technology and automation opportunities to improve agility, effectiveness, quality and productivity in support of PV Partnerships and PSTs.
  • Connects and shapes business system requirements and processes to successfully launch systems that meet business and compliance requirements.
  • Serves as the business lead in process improvement initiatives driven by the Business Process Office, and supports process documentation, training, CAPAs and metrics.
  • Develops, delivers and maintains Office of the PST technology solutions educational curriculum related to PV Partnerships.
  • Plans and conducts best practice and knowledge sharing forums in order to deliver operational excellence across PV Partnerships including members of the PSTs and affiliates.
  • Play a critical role in ensuring excellent health of the PV Partnerships by developing key performance indicators in addition to analyzing and distributing metrics. Provides broad recommended actions to improve metrics and compliance and seeks opportunities to drive implementation.
  • Builds enterprise level knowledge of processes and systems utilized within and beyond PPS that connects with PV Partnerships.
  • Drives project management support for PV Partnerships to enable PPS readiness for product launches. Set up project structure; develop project plan; confirm accountabilities, track completion of actions and escalate obstacles/risks. Manage updates to leadership.
  • Supports inspection /audit readiness activities by addressing document requests in a timely manner and ensuring document quality. Acts as a subject matter expert for PV Partnership process related inquiries during inspe ctions

  • Bachelor's degree in a healthcare discipline (i.e.: Life Science, Pharmacy, nursing or healthcare profession, or biomedical disciplines)
  • Masters or advanced degree is desirable
  • 5+ years project management or operational experience within global companies. Specifically working on process improvement or technology initiatives
  • At least 4 years' experience working in the pharmaceutical or healthcare industry and a strong understanding of the drug development process. Experience within Pharmacovigilance is not required but is desirable
  • Strong analytical skills and demonstrated ability to analyze large amounts of data, break issues down and assemble a cohesive perspective on future recommendations
  • Understanding of or familiarity with regulatory science concepts is desirable
  • Strong leadership presence. Demonstrated experience in courageously challenging the status quo and influencing others to adopt significant process changes
  • Experience in applying project management tools and processes such as status reports, charters, workplans, etc.
  • Experience in working directly with and influencing senior management including functional heads and line business owners
  • Demonstrated ability to work and collaborate with others, to consider the needs of all impacted groups, and to build/leverage relationships across functions and organizations to achieve business results. Decisive yet collaborative leadership st yle