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Quality
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186567 Requisition #
Thanks for your interest in the Vigilance Reporting Specialist position. Unfortunately this position has been closed but you can search our 420 open jobs by clicking here.
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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