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AbbVie Senior Manager, Global Safety Compliance in Maidenhead, United Kingdom

Senior Manager, Global Safety Compliance

United Kingdom, England, Maidenhead

2 additional locations

United KingdomUnited Kingdom, England

Regulatory Affairs

Requisition #1904550

SeniorManager, Global Safety Compliance

Based in our Maidenhead offices with up to 15% travel

Competitive salary, long term incentives, car allowance, bonus and comprehensive benefits package

Thecompany:

AbbVie is an ambitious health business where people and quality of life come first. The experience of illness is personal, so we care about the things that matter to patients. As market leader, we team with partners to co-design health solutions around our innovative medicines for complex diseases, which improve standards of care. Helping people to be fit for work and family life is how we make a remarkable impact to the lives of men, women and children.

Therole:

As The purpose of this role is to support the development, implementation, maintenance and monitoring of an optimised Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organisation that at a minimum meets global regulatory legal requirements and standards, and additionally promotes best practice and excellence. 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.

Highlightedresponsibilities:

  • Accountable for timely triage, impactassessment and investigation of issues, potential non-conformities, exceptionsand planned deviations, development of corrective and preventative actions(CAPA); proposing risk-proportionate and pragmatic solutions to improve thePharmacovigilance (PV) quality system and compliance; applying judgement andmaking risk-proportionate decisions based on experience and PV technicalknowledge. Verify completion and effectiveness of actions and ensure robustdocumentation.

  • Drive efficiency and consistency ofquality through utilization of quality system management practices.

  • Provide subject matter expertise andguidance to stakeholders in the conduct of high quality PV investigations andCAPA excellence. Plans and leads best practice and knowledge sharing forumswith internal stakeholders.

  • Support the development and execution ofthe PPS audit and inspection strategy, taking a leading role and providingsubject matter expertise in applicable internal audits and external inspectionactivities and facilitates responses with Subject Matter Experts (SMEs) and PPSLeadership to ensure complete, compliant, and timely action plan completion.

  • Responsible for tracking, statisticalanalysis and evaluation of quality data to assimilate trends and improvementrecommendations.

  • Contribute to impact assessments ofchanges in worldwide PV regulations and guidelines and provides recommendationsfor process changes and associated action plans in conjunction with BPO andSubject Matter Experts to ensure alignment with new legislation.

Qualifications& Experience

  • Bachelor’s Degree/equivalent in relatedscience field or relevant experience

  • Required: proven pharmaceutical or qualitysystem experience; preferred practical pharmacovigilance experience

  • Understanding of the value of a PV QualityManagement System

  • Experience of working with global colleaguesin a process improvement environment

  • Ability to function independently, influence awide range of stakeholders and problem solve effectively

Additional Information

  • Travel: Yes, 15 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time

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