Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Please note the MIS role will operate 2 days onsite our Burton office 3 days WFH.
We are currently seeking a Medical Information Specialist (MIS) on an initial 12-month FTC (maternity cover). This exciting role is ideal if you have previous experience working in a busy pharmaceutical medical information (MI) team or department, looking to further your career by assisting in the growth and overall management of a highly skilled MI team. You will be responsible for helping ensure the delivery of a high-quality MI service which is in compliance with all regulations and company policies and in accordance with any Pharmacovigilance and MI service agreements.
Grow an in-depth understanding of Clinigen products, disease areas and the self-regulatory framework the pharmaceutical industry works within.
Manage MI enquiries in a timely manner for Clinigen products and MI enquiries for other Pharmaceutical Client products, where Clinigen is contracted to provide MI support, ensuring all pertinent regulations and processes are adhered to.
Ensure all patient safety issues and product quality complaints are escalated appropriately and in line with standard operating procedures
Perform reconciliation activities of received medical Information enquiries, product complaints and adverse events with other internal and/or external stakeholders as required.
Frequently Asked Question (FAQ), Standard Letters and Data on File documents.
Perform literature searches to support medical Information activities.
Stay up to date with EFPIA and UK ABPI Code of Practice and share best practice with product and medical teams
Review of promotional materials ensuring that scientific and medical data are quoted accurately, that references are appropriate, current and accurately cited
Contribute to quality related activities including change control management, CAPA (Corrective and Preventative Action) and deviation management.
Represent medical information in internal and external audits and inspections, as required.
Assist in maintaining, improving and promoting the Medical Information service through management of projects and training of or liaison with other groups or customers.
Represent medical information at external meetings, as required.
Demonstrable experience in Medical Information in the Pharmaceutical Industry with an awareness of the ABPI Code of Practice
Patient and customer insight through experience in the pharmaceutical industry
Qualified up to BSc or equivalent life science degree and preferably a UK Registered Pharmacist
27 days holiday plus 8 bank holidays
~ Pension contributions 4.Life assurance 4 x annual salary
~ Flexible Benefits Platform with £25/month Company contribution
~ Annual salary review
~ Independent financial advice service
~ Enhanced Employee Assistance Programme
~ Shopping discounts with retailers
~ Long service awards
~ Recognition scheme & employee of the year awards