Vigilance Reporting Specialist
Our client is a multi-speciality healthcare company focused on discovering and delivering innovative products for the pharmaceutical industry. In partnership with the medical community, they bring scientific excellence and rigour to deliver leading products that improve patient outcomes.
Vigilance Reporting Specialist's Key Responsibilities include:
* Analysing and managing all requests related to complaints and adverse events from Competent Authorities, Notified Bodies and other external or internal requesters
* Collaborate with the Quality Engineering group.
* Support 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 our client's site.
* Work in compliance with the relevant regulations and company protocol
Candidate requirements for this role include:
* 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 of vigilance reporting within EEA and EAME region. Includes Council Directive 93/42/EEC (Medical Device Directive).
If this role is of interest, please contact Alex Russell on 01225 336335
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.