Medical Information / Regulatory Affairs Executive Contract

Medical Information / Regulatory Affairs Executive Contract – London

Opportunity:

This is a brand new opportunity that has been created due to various project work.

My client based in Central London a leading pharmaceutical company is looking to recruit a Medical Information / Regulatory Affairs Executive to be part of the Product Information Compliance team delivering a high priority safety update project, for a generic portfolio of products across wide therapy areas. This will be for the EU and Rest of World territories where you will determine all products within the Company (worldwide marketing authorisations) that require updates from a safety perspective.

Day to day duties and responsibilities will include:

• Performing medical updates and supporting regulatory affairs to complete relevant submissions to the local regulatory authorities.

• Medically and scientifically assess the relevant product information and carry out online literature searches to produce up-to-date scientific documents for the products marketed by the company, including summary of product characteristics (SPCs), patient information leaflets/literature (PIL) and Clinical Expert Statements (CESs).

• Conducting Periodic Safety Update Reports (PSURs).

• Annotate SPCs and PILs having a strong understanding of Quality Review of Documents (QRD) and non-QRD requirements, System Organ Class (SOC) and MedDRA coding.

This is initially a 6 months fixed term contract with a great salary and benefits!

Skills:

To apply for the role of Medical Information / Regulatory Affairs Executive you will have the following:

• Life science degree.

• Pharmaceutical Medical Information / Regulatory Affairs experience in carrying out the above duties.

• Excellent working knowledge of SmPCs and PILs (QRD/non-QWRD) and relevant Pharmacovigilance/safety requirements.

How to Apply:

If this sounds like the role for you or a colleague then please don’t hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.

For a list of our current vacancies, please apply.

If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.

Quality Start are acting as a specialist recruitment consultancy for this role.