Global Quality Lead, Pharmacovigilance Auditing, Systems and Compliance

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Date: Jun 26, 2019

Location: Braine L'alleud, Walloon Brabant, BE

Global Quality Lead, Pharmacovigilance Auditing, Systems and Compliance Quality Assurance

Location: Braine l’Alleud or Bulle, Belgium or Switzerland 
 
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 Corporate Pharmacovigilance Quality Assurance team, based in our hub in Braine l’Alleud or Bulle, Belgium or Switzerland, we are looking to fill the position of: Global Quality Lead, Pharmacovigilance Auditing, Systems and Compliance.
Do you describe yourself as helpful? Are you a futurist? Add these two together and you're a ‘helpfulurist’ at UCB. This unique blend of talent means you are a cooperative forward thinker with patient wellbeing in mind.
As a UCB 'helpfulurist' and Global Quality Lead, Pharmacovigilance Auditing, Systems and Compliance you like to work in an environment where you can:

• Co-creates and/or implements a strategy. 

• Interface directly with representatives from Regulatory Authorities across the world.

• Travel nationally and internationally as business necessitates, 30% of time on average.

• Flexibility in terms of working hours and homeworking.
As a UCB 'helpfulurist' and Global Quality Lead, Pharmacovigilance Auditing, Systems and Compliance you will contribute by:
• Executing the Pharmacovigilance audit program (including audits of Critical Processes, Affiliates, Licensing Partners, Service Providers/Vendors).

• Performing qualification PV audits of potential new vendors/partners.

• Proactively managing findings, responses and CAPAs, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns.

• Leading and/or participating in the development of the risk based PV audit program through evaluation of elements of the UCB clinical safety and Pharmacovigilance quality system.

• Leading the preparation, hosting and follow up of Regulatory Authority inspections related to clinical safety and Pharmacovigilance activities at the Central sites, and Affiliates.

• Participating actively on the PV Quality Council and interacting directly with colleagues, escalating concerns and providing expert guidance on PV compliance issues.

• Contributing data and feedback to Patient Safety and other functional groups relating to Key Quality/Performance Indicators and quality compliance status.

• Managing external auditors and/or vendors as required, ensuring that findings from pharmacovigilance audits are distributed, responsed and CAPAs are tracked and followed up.

• Playing an active role as Business QA in validation of computerized systems supporting UCB’s Pharmacovigilance System.

• Participating in medium-long term projects within competence.
Interested? For this position you’ll need the following education, experience and skills:
• In depth knowledge of Pharmacovigilance systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GVP principles, and practice. Able to apply theoretical knowledge in practical situations.

• Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy.

• Familiarity with statistical principles and data analysis.

• Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with external inspectors, and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.

• Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process.

• Effective verbal and written communication skills in English. Should be able to adapt communication style to suit different audiences/cultures.

• Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others.

• Ability to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations.


To apply please go to www.ucb.com/careers
Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.


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