Job Ref: 213591718

Date: 2021-04-21 15:43:17

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Drug Safety Specialist (Case Management) required for a 12-month contract role with a leading multinational client based in High Wycombe.

Responsibilities
• Ensure oversight of vendors involved in the Covid-19 vaccine release.
• Main point of contact for oversight mechanisms and to relay this data to the leadership team.
• Become an SME in Covid-19 vaccine case management processes.
• Creation of training slides, slide decks and perform quality checks in relation to vendor processes.
• Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
• The scope of support is primarily focused on regional Covid-19 cases.

Requirements
• A degree in life, health or pharmaceutical sciences is preferred.
• Proficiency in Medical terminology (local languages).
• Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
• Computer literate with expert knowledge of the Intake (GIRS) and/or expedited reporting (OST) module(s).
• Knowledge and understanding of key legislation applicable to pharmacovigilance within.
• Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable.

Interested candidates should submit an updated CV
Please click the link below to apply, call Alba on (phone number removed) or alternatively send an up to date CV alba@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert

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