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PV Quality Qualification Manager

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  69117

Pharmacovigilance Quality Qualification Manager

 

To strengthen our Global Quality Assurance department, preferably based in our hub in Braine l’Alleud, we are looking for a talented individual to fill the position of: Pharmacovigilance (PV) Quality Qualification Manager.

 

As a UCB PV Quality Qualification Manager, you like to work in an environment where you can:  

  • Ensure Pharmacovigilance (PV) Quality Assessment of third parties to whom PV activities will be delegated by UCB Affiliates across all territories (Europe, USA, International Markets). 
  • Work with key stakeholders in UCB Affiliates and in UCB’s Corporate Quality and International Pharmacovigilance Organizations to ensure the Qualification is performed, documented, and communicated in accordance with UCB procedures as well as Good Pharmacovigilance Practice (GVP).
  • Through collaboration with an external consulting company, oversee the development, launch, and management of a vendor qualification “tool” to support PV qualification within UCB.

 

As a UCB PV Quality Qualification Manager, you will contribute by:

For the PV qualification act as a central contact point for all the steps linked to the coordination of the PV qualification for Affiliate Third Parties.

 

Understand the big picture and high-level steps (including operational steps) on qualification in general and its applicability for vendors impacting pharmacovigilance:

  • Maintaining central oversight and tracking of all the ongoing vendor qualifications for Affiliate Third Parties impacting the PV System.
  • Maintaining the PV qualification mailbox and Electronic Document Management System (eDMS) with PV Qualification outputs.
  • Ensuring PV vendor qualification coordination steps are executed within defined timelines (e.g. PV decision tree, PV questionnaire…).
  • Scoring and reviewing for completeness the PV questionnaire following vendor completion.
  • Redirecting, liaising and following up within appropriate UCB stakeholders (PVQA, LSO or local QA) any questions raised by the vendor in the frame of questionnaire completion.
  • Drafting the PV qualification summary report by collecting all the elements from the PV qualification steps. Being able summarized PV issues and associated remediations following PVQA/local QA vendor documents review feedback.
  • Developing and implementing KPI on the number of PV vendor qualification (e.g. quantitative, qualitative, etc).

 

Ensure deployment and management of the global PV vendor qualification “tool” to support PV qualification within UCB.

 

  • Being accountable for the data and business processes managed and/or supported by the “tool”.
  • Being the main contact interface between UCB and Third-Party vendor implementing the “tool”
  • Ensuring complete rollout and use of “the tool” on a global basis in collaboration with other Quality groups and applicable business areas such as, external vendor IT, Safety….
  • Ensuring appropriate processing of data in accordance with data integrity principles, set of access criteria and related restrictions, processing of data retention in alignment with regulations.
  • Ensuring that “the tool” is maintained in a state of compliance ( (CSV), current procedures, etc.).
  • Ensuring that new guidelines/regulations relating to the management of PV Qualification of vendor are being implemented within the tool when required.
  • Being responsible for the data within “the tool” (QC) and able to develop and produce KPI, reporting.
  • Being responsible for the inspection and audit readiness for “the tool” under the scope of PV qualification .
  • Being responsible for ensuring that all system users are adequately trained.
  • Being responsible for long term strategic planning for “the tool” (evolution) under scope of PV qualification in collaboration with stakeholders.

Interested? For this position you’ll need the following education, experience and skills:

  • Master’s degree in related field
  • Very strong background in PV Qualification ( mindset)
  • Good understanding of quality aspects, knowledge of GVP and applicable regulatory framework.
  • Ability to lead projects medium complexity project.
  • Experience with Computerized System (CSV)
  • Experience with / Data Owner (PDO) role is an advantage
  • Ability to effectively interact with and influence internal and external groups.
  • Strong managerial and organization skills.
  • Experience of working with software tools in a pharmaceutical regulated environment.
  • Ability to analyze data and information to draw conclusions and make effective decisions while taking into account the balance of compliance and business risk.
  • Effective verbal and written communications skills.
  • Experience working in International / Multi cultural environment.
  • Fluent in verbal and written English
  • Hands-on person but strategical mindset as well with long-term vision

 

Apply now »