Sr Auditor, Pharmacovigilance Quality Assurance Professional 9/1/2016
JOB DESCRIPTIONAPPLY We all share one big ambition. What's yours?
Everyone who works at UCB holds the same ambition - to transform the lives of people living with severe diseases. Of course we have other associated ambitions too - including a desire to support each other in attaining all of our own personal and professional goals. That's why we ensure every UCB colleague has the tools and environment to engage effectively in the work we do. Wherever in the world we're based, and whatever role we play, we believe each of us can have an impact across our organization.
Our challenge. Your impact.
We aspire to be the Patient Centric global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.
For our Pharmacovigilance Quality Assurance team, based at UCB s USA site in either Atlanta, GA or Raleigh, NC, we are looking for a:Pharmacovigilance Quality Assurance Professional
The Pharmacovigilance Quality Assurance Professional will be in charge of implementing a strategy, including delivery of a risk based audit program covering the quality and compliance of the UCB Pharmacovigilance System(s).
She/he will be also responsible to provide input and advice to processes and areas impacted by Good Pharmacovigilance Practice (GVP) with respect to the requirements of global and local regulations, guidelines and industry best practice
Critical responsibilities for this role include, but are not limited to:
* Execute the Pharmacovigilance audit program (including audits of Central sites, Affiliates, Licensee, Contractors, specific processes and safety documentation) in support of clinical safety and Pharmacovigilance activities related to UCB products.
* Proactively manage findings, responses and CAPAs arising from audits in the Audit Database, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
* Participate in the development of the risk based PV audit program through evaluation of elements of the UCB clinical safety and Pharmacovigilance quality system and their effect on the overall state of compliance of the system.
* Lead the preparation, hosting and follow up of Regulatory Authorities inspections related to clinical safety and Pharmacovigilance activities at the Central sites, and lead or assist at Affiliate inspections as deemed necessary and practicable.
* Through active participation on the PV Quality Council and through direct interaction with colleagues, escalate concerns and provide expert guidance on PV compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
* Contribute data and feedback to Patient Safety, the Affiliate Network, and other functional groups relating to Key Quality/Performance Indicators and quality compliance status.
* Manage external auditors as required, ensuring that findings from internal audits are distributed, and responses and CAPAs are tracked and followed up as necessary in the Audit Database.
* Play an active role as Business QA in validation of computerized systems supporting UCB s Pharmacovigilance System
* Upon the request of/with the approval of the Head PVQA, perform other tasks within competence (as determined by relevant training, experience and/or qualifications).
* Master s degree in a relevant scientific field
* Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in Pharmacovigilance-related areas.
* Experience in leading full range of Pharmacovigilance audits for internal processes/units and external partners or vendors, and in managing/hosting regulatory inspections or third party audits with depth of understanding of the theory and practice of quality management.
* In depth knowledge and understanding 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.
* Demonstrated self-starter, highly reliable, with positive, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
* 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.
* Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
* High level of personal integrity with a strong commitment to patient welfare and ethical behavior.
* Fluent in written and spoken English. Additional language skills would be an advantage.
* Able to travel nationally and internationally as business necessitates, up to 30% of time on average
UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system - or the central nervous system.
With more than 8500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a 'can-do' attitude can thrive. Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB.
UCB and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer. Minority/Female/Disability/Veteran