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Let's push the boundaries together and make the most of your talents!

Data Quality Excellence Lead

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  67811

Data Quality Excellence Lead

 

Help us transform patients’ lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe 
disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.

Will you join us in our pioneering adventure?

To strengthen our Global Patient Safely department, based in Braine l’Alleud, Belgium, we are looking to fill the position of: Data Quality Excellence Lead.

As a UCB Data Quality Excellence Lead you like to work in an environment where you can:

  • Develop and optimize safety business processes in alignment with safety system functionalities to ensure quality, compliance and integrity of single safety case handling.
  • Oversee case processing of solicited and spontaneous individual case safety reports by identifying regulatory changes and assessing their impact on current processes; communicating any necessary actions up to management as well as to the operational processing centers; and assist in driving projects that improve the use of systems in adverse event reporting and submissions.
  • Effectively communicate information with regards to adverse event reporting, training, process improvements, and regulatory changes in the pharmacovigilance industry across functional teams and to external partners.

 

 

As a UCB Data Quality Excellence Lead, you will contribute by:

  • Having thorough and expert knowledge of not only pharmacovigilance theory, regulations, and application but also has knowledge of safety systems (Argus) and how pharmacovigilance fits into the larger scope of the drug development cycle
  • Serving as subject matter expert on adverse event reporting and submission within patient safety and other cross functional areas
  • Leading the review and the implementation of robust communication and interfacing processes with PV outsourcing and strategic initiative partners to ensure all outsourcing activities meet business and regulatory objectives
  • Providing pharmacovigilance expertise and insight on process improvements and being able to initiate discussion with manager for implementation of any necessary actions
  • Enhancing overall quality of ICSRs by overseeing completion of various activities that contribute to the compliance of ICSRs, including system implementation and validation, and working with the other teams including but not limited to QC team, safety physicians, local safety officers, and external vendors as needed
  • Writing and maintaining SOPs regarding ICSRs. Providing insight and initiating any changes needed due to changing business need, system requirements, or regulatory changes.
  • Providing oversight and delegation of all received e-mails within the team mailboxes.
  • Being able to coordinate, motivate, and lead small teams/workstreams within Safety Data Insights (SDI) for the successful completion of tasks and address any applicable issues that may hinder completion of deliverables within Patient Safety (PS)
  • Being able to communicate within PS and across departments in technical/scientific language to generate discussion on issues or regulatory changes but also able to communicate complex topics and information in layperson's terms as needed
  • Anticipating risks and developing solutions independently
  • Providing backup for the Head of the DQE team, when needed
  • Being able to act as a mentor to the rest of the DQE Team
  • Providing training to internal and external partners as needed
  • Being able to deliver presentations or reports to senior management, departmental teams, or industry audiences in a clear, relaxed, and proficient manner
  • Performing other tasks as deemed necessary by the department and Company

 

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

  • Bachelor’s degree and/or Registered or Licensed Nurse or Pharmacist
  • Experience in the pharmaceutical industry with experience in pharmacovigilance department or a clinically- oriented discipline, including significant experience in the conduct of clinical studies and/or experience in the compilation or the analysis of aggregate safety data.
  • Must have at least 5 years’ experience in safety case processing; as per PV regulations.
  • Ideally a previous experience dealing with Deviations, CAPA, change control
  • Must have leadership qualities in leading other team members or teams.
  • Ability to interact with various stakeholders (internals, externals)
  • Ability to contribute to continuous improvement processes
  • Excellent organizational, inter-personal, diplomatic, and leadership skills.
  • A logical thinker with meticulous attention for detail while maintaining an overall view. Strong scientific sense with a responsible attitude.
  • Good written and oral communication skills, fluency in English
  • Knowledge of regulatory pharmacovigilance requirements and use of query tools or databases constitutes an asset.
  • Excellent problem solver
  • Good team player, helpful and generous to others
  • Proactive identification of issues requiring solutions
  • Ability to think ‘outside of the box’ to propose innovative solutions

 

Apply now »