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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Manager, Global Safety Compliance

Maidenhead, England, United Kingdom Req ID 2210217 Category Research and Development Division AbbVie

Job Overview:

As a Senior Manager, you will be responsible to support the development, implementation, maintenance and monitoring of an optimized Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organisation.

The position ensures that we promote best practice and excellence, and the scope extends to pharmacovigilance activities worldwide and spans the life cycle of all products. The Safety Compliance team partners with a wide range of stakeholders within PPS, across Research & Development, and the Commercial organisation, engaging at both corporate and affiliate locations.

Key Responsibilities:

  • Accountable the development of corrective and preventative actions (CAPA); proposing solutions to improve the Pharmacovigilance (PV) quality system and compliance
  • Drive efficiency and consistency of quality through utilization of quality system management practices
  • Provide subject matter expertise and guidance to stakeholders in the conduct of high quality PV investigations and CAPA excellence. Plans and leads best practice and knowledge sharing forums with internal stakeholders
  • Support the development and execution of the PPS audit and inspection strategy
  • Responsible for tracking, statistical analysis and evaluation of quality data to assimilate trends and improvement recommendations
  • Contribute to impact assessments of changes in worldwide PV regulations and guidelines and provides recommendations for process changes
  • Support the collection of PV system performance and compliance metrics and drives continuous improvements
  • Responsible for effective, appropriate and up to date PPS Quality System documents (including requirement and supporting documents) in support of the PV System

  • Bachelor’s Degree or equivalent experience in related science field
  • Proven pharmaceutical or quality system experience; preferred practical pharmacovigilance experience
  • Understanding of the value of a PV Quality Management System
  • Experience of working with global colleagues in a process improvement environment
  • Ability to function independently, influence a wide range of stakeholders and problem solve effectively
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time

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