Clinical Project Specialist

1 month ago


Burton upon Trent, Staffordshire, United Kingdom Clinigen Full time
Job Opportunity

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 seeking a Medical Information Specialist to join our team on an initial 12-month fixed-term contract. This exciting role is ideal for individuals with previous experience working in a busy pharmaceutical medical information team or department, looking to further their career by assisting in the growth and overall management of a highly skilled MI team.

The successful candidate will be responsible for ensuring 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.

Key Responsibilities
  • Develop 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.
  • Conduct literature searches to support medical Information activities.
  • Review and approve in a timely manner agreed materials and activities within area(s) of defined MI accountability.
  • Stay up to date with EFPIA and UK ABPI Code of Practice and share best practice with product and medical teams.
  • Review 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.
Requirements
  • Demonstrable experience in Medical Information in the Pharmaceutical Industry with an awareness of the ABPI Code of Practice.
  • Excellent communication skills – both written and verbal.
  • Evidence of effective team working and time management.
  • Patient and customer insight through experience in the pharmaceutical industry.
  • Problem-solving skills and the ability to think strategically.
  • Attention to detail working in a fast-paced environment and a strong communicator.
  • Previous experience working in an MI service provider preferable.
  • Qualified up to BSc or equivalent life science degree and preferably a UK Registered Pharmacist.
Benefits
  • 27 days holiday plus 8 bank holidays.
  • Pension contributions 4.5% matched.
  • 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.


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