Clinical Project Specialist
1 month ago
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.
- 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.
- 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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