Director PV Process Vendor Management

Position

As a Director PV Process Vendor Management you are responsible for developing strategies, procedures and program management for all outsourcing activities for PV Process, as well as supporting outsourcing initiatives for other GPV functions. You ensure the quality, compliance, and cost- effectiveness of work delivered under multiple business process outsourcing contracts for critical safety services within PV Process (including but not limited to adverse event case reporting) and you ensure global consistency. You will manage a significant portion of the GPV budget and directly impact regulatory compliance. Besides this you will lead and establish contract parameters, collect key metric information and identify/implement continuous improvement initiatives with the vendor(s). You will also be responsible for overall vendor performance and ensuring service outputs are delivered on budget. You contribute to the development of the future case processing and outsourcing model(s) to achieve cost-effectiveness of contracted work.

Profile

• minimum BA/BS, preferably with an advanced professional degree

• minimum of 10 years relevant experience in the pharmacovigilance or combined PV/RA/QA and/or clinical development, including extensive leadership experience,
  including ability to lead and manage a global, multidisciplinary teams

• planning, forecasting and budgeting skills and experience

• minimum 3 years of experience working with CROs, vendors, and relationship management

• in-depth understanding of safety regulations for both marketed and investigational products and excellent knowledge of global health authority requirements including ICH,
  CFR 21, FDAAA, EU GVP module, JP

• strong interpersonal skills and multi-cultural/intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective
  relationships through collaboration

• advanced problem solving and negotiation skills in complex issues and able to decide independently

• excellent communication and presentation skills in English (written and spoken)