Medical Information Associate

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The role is responsible for the delivery of a high-quality medical information service to internal and external users across all business functions, compliant with external regulations and internal company policies.

The Medical Information Associate role is ideal for an individual with an awareness or understanding of medical information who is looking to develop or gain exposure in assisting the growth of a medical information department. Knowledge of pharmacovigilance is also an advantage.

Job Description

• Ensure the provision of an efficient, comprehensive and professional MI service to internal and external customers in line with industry standards.
• 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.
• Liaise with multiple internal and external stakeholders as required for handling of medical information enquiries.
• Accurate documentation of MI enquiries in the MI enquiry tracker.
• Ensure all patient safety issues and product quality complaints are escalated appropriately and in line with standard operating procedures.
• Respond to all medical information support requests from internal departments without delay and in a timely fashion and within the timelines as documented in internal procedures.
• Generate, distribute and track Monthly Line Listing reports to clients.
• Support the collation of MI Compliance metrics, Key Performance Indicators (KPI) and Quality Review reports.
• Perform reconciliation activities of received medical Information enquiries, product complaints and adverse events with other internal and / or external stakeholders as required.
• Update and communicate changes to product SPCs and Patient Information Leaflets to external and internal stakeholders (e.g. eMC, MIMS, BNF, distributors, partners, etc).
• Develop and maintain a thorough knowledge of the company's products.
• Ensure all pertinent regulations and processes are adhered to.
• Contribute to and ensure process and system improvement, including support of new services.
• Contribute to quality related activities including change control management, CAPA (Corrective and Preventative Action) and deviation management.
• Represent medical information in cross-functional team meetings, as required.
• Develop an understanding and stay up to date with the relevant industry codes of practice, eg. EFPIA, UK ABPI, Medicines Australia, Medicines New Zealand, HKAPI, PhAMA, and SAPI codes of Practice.
• Support the preparation and development of MI Standard Response Documents i.e. Frequently Asked Question (FAQ), Standard Letters and Data on File documents.
• Support preparation for medical information in internal and external audits and inspections, as required.

Requirements

Benefits

Seniority level

Associate

Employment type

Full‑time

Job function

Research

Industries

IT Services and IT Consulting

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