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Vigilance Reporting Specialist

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Quality
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186567 Requisition #
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Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
 
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
 
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
 
Reporting to the Associate Director Product Surveillance, the Vigilance Reporting Specialist will be responsible for:
  • Analysing and managing all requests related to complaints and adverse events from Competent Authorities, Notified Bodies and other external or internal requesters, collaborating with the Quality Engineering group.
  • Supporting the regional Product Surveillance team with its vigilance reporting activities as required and improving the vigilance reporting process across EAME.
  • Addressing general administrative tasks associated with the Quality System at Marlow site.
The employee must conduct their work activities in compliance with all relevant regulations as well as Allergan policies, procedures, values and objectives.
The employee is expected to be fully capable of performing all of the tasks encompassed within this role and may be given other activities, projects and assignments as required. The percentage of time spent on the different task areas as detailed in this job description is an indication only and will vary based on the department needs.
Education and Experience:
  • Science or related degree level qualification preferred or experience in a similar environment.
  • Experience in the healthcare, medical device or pharmaceutical industry is required.
  • Experience in Adverse Event handling and vigilance reporting in accordance with applicable MEDDEV guidance and European/Emerging Market regulatory requirements for post market activities is required.
  • Experience in direct interactions with Competent Authorities and other regulators is highly desirable.
Knowledge:
  • Expert knowledge of vigilance reporting within EEA and EAME region.  Includes Council Directive 93/42/EEC (Medical Device Directive). 
  • Good understanding of all other applicable regulatory requirements would be an advantage:
    • FDA’s 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 803 (MDR Regulation) and 21 CFR Part 11 (Electronic Records; Electronic Signatures). 
    • ISO 13485 and the Canadian Medical Device Regulations and the Australian Therapeutics Goods Administration regulations

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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