Assistant Director, Safety Deliverable Excellence

Lake County, Illinois, USA
Jul 12, 2018
Required Education
Bachelors Degree
Position Type
Full time
This position reports into the Office of the Product Safety Team (PST) Associate Director 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 maximizes 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.
This role leads the Safety Deliverable Excellence team and is responsible for driving excellence across all aspects of safety deliverable strategy including planning, development, quality and submission activities. Key Responsibilities Include:
  • Provide leadership, oversight and strategic direction for the Safety Deliverable Excellence team within the Office of the Product Safety Team. Responsible for hiring, coaching, training, onboarding and managing the performance for the team. Responsible for building and nurturing a culture of safety deliverable excellence across the team.
  • Develop, communicate and implement the vision, strategy, objectives and metrics (deliverable quality, timeliness and efficiencies) for safety deliverable excellence. Builds strong strategic partnerships with stakeholders and leverages relationships to advance the vision for safety deliverable excellence. Identify opportunities to expand impact of the team as well as enhance PST contributions to non-PPS owned submission deliverables.
  • Partner with the Business Process Office to develop process flows for safety deliverables. Accountable for ensuring compliance with implementation of process flows, including partnership with OOPST Resource Operations Team for outsourced safety deliverables. Partner with Safety Compliance to actively monitors compliance including performing periodic checks. Accountable for CAPAs related to safety deliverables.
  • Proactively identify opportunities to enhance safety deliverable processes and metrics. Develops compelling proposals for senior leadership review and gains endorsement. Provides execution leadership for all initiatives related to the safety deliverable excellence.
  • Accountable for audit and inspection preparation (related to safety deliverables) strategy and execution to ensure audit readiness activities are completed. Leads and oversees responses to audit requests. Sets the strategy for document requests during inspections and audits. Acts as a subject matter expert where required and may be interviewed during audits and inspections.
  • Proactively stay abreast of global regulations impacting safety deliverables and ensures compliance. Facilitates critical leadership discussions on evolving Regulatory Intelligence and Regulations that impact safety deliverables, conducts business assessments and drives initiatives to address gaps.
  • Accountable for all safety deliverable metrics. Conducts regular quality and timeliness checks. Collects, analyzes and communicates safety deliverable metrics (both internal and external such as assessor comments). Seeks to understand issues and root causes of deviations. Takes timely action to ensure compliance.
  • Represents PPS leadership on cross-functional initiatives (i.e. led by functions outside of PPS) that impact safety deliverables. Actively participates and provides PPS' perspectives and takes ownership of activities that impact safety deliverables. Provide leadership on PPS initiatives impacting safety deliverables.
  • Accountable for decision making on resource utilization of Safety Deliverable Managers. Seeks creative ways to utilize limited resources and works with the Associate Director, OOPST Operational Excellence to address critical resource needs.
  • Promote culture of safety deliverable excellence across PPS and contributing author organizations.
  • Bachelor's degree in business or science related field (i.e.: Life Science, Pharmacy, nursing or healthcare profession, or biomedical disciplines) required
  • Masters or advanced degree is desirable
  • At least 5 years' experience working in the pharmaceutical industry. Experience within Pharmacovigilance, medical writing, quality and/or Regulatory Affairs organization is desirable but not required.
  • Experience managing deliverables submitted to Regulatory Authorities.
  • Understanding of PV regulations. Understanding of the connections between regulations and science for the benefit of drug safety.
  • Significant leadership and people management experience.
  • Experience in directly leading and driving major change initiatives within a team. Strong leadership presence and demonstrated ability in courageously challenging the status quo and influencing others. Experience in working directly with and influencing senior management including functional area leaders.
  • High emotional Intelligence and strong relationship management and communication skills
Equal Opportunity Employer Minorities/Women/Veterans/Disabled