• This position reports into the Office of the PST (part of the Strategy Management Office) in the Pharmacovigilance and Patient Safety (PPS) organization. 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 Product Safety Team Project Management group (PST PM) plays a critical role in shaping and driving the strategic priorities of the PST through providing exceptional and strategic project management leadership. 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.

   

  Responsibilities:

   

   

• In partnership with PST Lead, shape the PST strategic priorities and drive implementation by applying strong understanding of Therapeutic Area, regulatory science, signal management & project management to influence characterization of the compound/product safety & effectiveness profile. This responsibility will be accomplished through building strong and trusted relationship with the PST Lead
• In partnership with the PST Lead, manage multiple Product Safety Teams across multiple Therapeutic Areas. This includes meeting planning and facilitation, meeting minutes documentation and post- meeting/general team management activities. Increase meeting productivity and advance decision- making effectively through the application of strong skillsets in strategic thinking, influence, leadership, relationship building, proactive-ness, curiosity and active engagement.
• Proactively utilize experience and knowledge to support the PST Lead in framing safety issues and making decisions. Anticipate possible outcomes of safety issues and provide guidance to the PST Lead so that he/she can be proactively prepared. Systematically analyze the impact of safety decisions and connect the dots across other decisions, discussions and actions across the organization. Communicate perspectives to PST Lead and recommend solutions.
• In partnership with PST Lead, manage escalation of safety issues and decisions to management and Safety Review Board (SRB). Create escalation documentation (e. g. SRB presentations) and help prepare the PST Leads for discussions. Manage the close-out of SRB action items for assigned PSTs.
• Support the PST Lead in strengthening internal partnership/influence and establish role as the company leader of safety issues related to their compounds/products. Identify new opportunities for the PST Lead to build relationships and present thought leadership to peers.
• Support the PST Lead in strengthening external engagement/presence by providing recommendations on channels for expanding external engagement including topic ideas for publications, conferences to present at key industry relationships to develop, etc. Support the creation of content for external engagement activities.
• Drive timely development of key PST deliverables by planning and facilitating productive working sessions to create deliverables; share perspectives; push the thinking to create robust deliverables, suggest improvements, and connect the dots.
• Support inspection /audit readiness activities. Engage in supporting PST-related inspection/audit activities and CAPAs/commitments.

•BA/BS (prefer nursing or pharmacy, or healthcare professional), with 6+ years clinical or pharmaceutical experience.
•Education in biological/medical science or healthcare professional MA/B/MS (advanced degree preferred).
•Pharmaceutical Industry work experience (7 years).
•Ability to work independently, influence stakeholders, and present sound business strategies.