Head of QPPV

AbbVie

Maidenhead, United Kingdom

Objective:

The purpose of this role is to provide dynamic leadership to the QPPV Office in order to meet its primary functional objective of ensuring all area/regional and National QPPVs meet their regulatory obligations. This includes oversight of all QPPV training, qualification and establishing the necessary governance forums and procedures to bring about comprehensive QPPV oversight of the AbbVie PV system.

This role is critical to the International PV Network, with its goal of delivering an effective Area PV model and executing product PV strategies across AbbVie affiliates.

Highlighted responsibilities include:

  • Ensuring robust QPPV oversight of product safety profiles and emerging safety concerns through integrated PST support, critical review of scheduled and ad hoc safety deliverables and the fulfilment of International/ EU QPPV obligations during planned and unforeseen periods of absence;
  • Leadership (matrix may be required) and management oversight for all QPPV Office staff and functional objectives;
  • Responsible for establishing and maintaining all QPPV governance procedures and mechanisms to allow AbbVie’s International QPPV Network to always meet mandated regulatory obligations world-wide;
  • Establish and lead comprehensive International QPPV Network oversight forums and ad hoc communication channels to facilitate timely and robust QPPV information sharing, decision-making and PV system governance;
  • Provides strategic direction for International PV Network, working collaboratively with relevant PPS stakeholders to deliver a robust Area PV model and execute product PV strategies across AbbVie affiliates.

Qualifications, Knowledge and Experience:

  • Medical Doctor background (Advanced degree is preferred);
  • Must have comprehensive working knowledge of international PV legislative requirements, including QPPV obligations, and practical experience of reviewing all PV safety deliverables;
  • Experienced in maintaining an effective and compliant PV quality system;
  • Ability to build strong relationships and influence colleagues to achieve cross-functional alignment;
  • Motivational approach, open to new ideas and the ability to connect the dots within and across teams and functions;
  • Excellent written and verbal communication skills.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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