Chase
Job title:
Medical & Regulatory Affairs Officer – Lincoln Office Based
Company
Chase
Job description
Medical & Regulatory Affairs Officer – Gastroenterology – Lincoln Office Based
Our client is a medium sized internationally established Pharmaceutical company that focuses on the development, in-licensing and marketing of prescription products for the treatment of gastrointestinal diseases. They are well established in the UK and with product line extensions and new product launches will see their sales and growth continue to rapidly expand.
A new opportunity exists for a Medical & Regulatory Affairs Officer, based from their Lincolnshire offices.
This role is responsible for providing support to their Medical and Regulatory departments including, but not limited to, lead role in adverse event reporting and medical information responses, maintaining up to date product information documents (SmPCs, PILs, PIs), annual submission of transfer of value data, and examination of print promotional and non-promotional materials
Key responsibilities include:
- Provide compliance support to TPUK colleagues
- Provide a high level of support to the Senior Regulatory Affairs Manager
- Answer telephone/email medical information enquiries from external sources relating to the company products
- Deputy Responsible Person providing support to Responsible Person (RP) to maintain compliance with Good Distribution Practice (GDP) rules and guidance
- Deputy Local Safety Officer (dLSO) providing support to Local Safety Officer (LSO)
- Provide ABPI Code of Practice and Pharmacovigilance training for new starters as part of induction training
- Examine printed promotional and non-promotional material to confirm they accurately reflect the electronically certified final prior to use
- Compile and submit annual Transfer of Values Disclosure by the required deadline collaborating with Finance, Medical, Marketing, and Sales teams as required.
- Update Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) on the Electronic Medicines Compendium website in line with updates as approved by the National Competent Authority for all TPUK medicinal products
- Ensure updated Prescribing Information (PI) is drafted, reviewed, and approved for all TPUK medicinal products as required in line with SmPC updates
- Provide support for completion of formulary submissions on request
The ideal qualifications and experience are:
- Pharmacy or Life Sciences degree
- Likely to be a current pharmacist from either a community, primary or secondary care setting
- Previous experience in the pharmaceutical industry
- Knowledge of ABPI Code of Practice
- Knowledge of Pharmacovigilance and Good Distribution Practice (GDP)
- Ability to accept responsibility and be proactive
- Good verbal and written communication skills
- Good telephone manner
- Good organisation and time management
- Excellent word processing skills – Word, Excel, PowerPoint
Excellent basic salary, healthcare, pension + bonus
For further information please apply online or contact CHASE on 0131 553 6644.
Reference number: 33741
Expected salary
Location
Lincolnshire
Job date
Wed, 17 Jan 2024 08:46:17 GMT
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