Product Vigilance Assistant

Gold Group Ltd.
08 Mar 2018
14 Mar 2018
Contract Type
Full Time

Product Vigilance Assistant

Product Vigilance Specialist needed for a multinational Pharmaceutical organisation based in Berkshire who are looking to employ an experienced Product Vigilance Specialist with a working understanding of drug development and pharmacology.

The successful Product Vigilance Specialist will want to work for this client not just because it's a great opportunity but also because they will receive a pay rate of up to £21.25 per hour.

What the role entails:

Support the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.

Some of the main duties of the Product Vigilance Assistant will include:

Inbound Case Management:

* Receipt and processing of incoming safety information from multiple sources, both internal
and external to the Company
* Entry of relevant/required safety data into the Global Safety Database from spontaneous
sources, clinical trials and other solicited sources.
* Provision of safety information/acknowledgement to marketing partners/other third party
partners/Global Medical Safety within the internal and contractual timelines
* Requesting additional information from multiple sources, both internal and external to the
* Assist with assessment of incoming information from multiple sources, both internal and
external to the Company
* Assist in the quality review of data captured in the Global Safety Database

Outbound Case Management:

* Continual monitoring and assessment of reportability of Individual Case Safety Reports
due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and
* Notified Bodies (British Standards Institution (BSI)
* Quality review of expedited assessments prior to submission
* Provision of safety information to Competent Authorities/Notified Bodies within required
regulatory timelines

Additional Activities:

* Accurate and timely documentation of deviations to process/timelines. Including root
cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
* Support all occurrences of internal and external audits and inspections
* Ensures all assigned training is completed in a timely manner
* May be involved in mentoring/training of staff and/or third-party partners with
* respect to pharmacovigilance
* May be involved in completion of periodic reconciliation activities.

In order to be the successful Product Vigilance Specialist and have a chance to gain such an exciting opportunity you will ideally need to have the following:

* Awareness of and familiarity with industry principles of drug development and
* Proficiency in global and local SOPs
* Computer literate with expert knowledge of the Global Safety Database and/or expedited
reporting module(s)
* Ability to prioritise and work to strict timelines on a daily basis
* Excellent verbal and written communication skills
* Ability to negotiate and communicate with internal and external customers
* Ability to work effectively as a member of the Drug Safety and broader Medical
Department teams
* Knowledge and understanding of key legislation applicable to pharmacovigilance in the
* UK and Ireland
* Proven expertise and experience in pharmaceutical regulations and R&D processes is

This really is a fantastic opportunity for a Product Vigilance Specialist to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!

This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview.

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