Medical Affairs Officer
Norgine, United Kingdom

Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 22 million patients around the world in 2019 and generated 419 million in net product sales, a growth of 6% over 2018.

Norgine has a direct presence in 12 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.

Role: Medical Affairs Officer

MAIN PURPOSE:

• Primarily responsible for first line provision of medical information response handling and medicinal product and device safety reporting as well as providing administrative support for the UK Medical Director amp; Medical Affairs Department
• Collaborate with and work under supervision of Medical colleagues to provide end to end Medical Information and library services to Norgine Pharmaceuticals Ltd.
• Manage all Medical Educational Goods and Services (MEGS)/ third party sponsorship (TPS) requests and compile UK Annual declaration for Transfers of Value (ToV)
• Provide support for UK pharmacovigilance activities
• Provide administrative support for the UK Medical Director amp; Medical Affairs Department
• Responsible for maintaining Medical Archiving
• Work closely with other department members in line with all necessary compliance requirements
• Ensure Norgine Pharmaceuticals Limited remains compliant with applicable Copyright laws as well as GDPR

KEY RESPONSIBILITIES amp; ACCOUNTABILITIES:

MAIN TASKS:

Medical information activities

• Answer telephone/email enquiries from external sources relating to the company products in a professional and timely manner.
• Record and respond to requests from the sales-force to provide medical literature to HCPs
• Perform literature searches in response to specific medical enquiries
• Research scientific materials to continually update and expand current Information held on Standard Response Documents (SRDs) so that approved additional information can be provided to HCPs and members of the public
• Enter and process enquiries received into the Medical Information Database.
• Identify and report adverse events and product quality complaints within reporting timelines
• Ensure that any follow up information related to an adverse event is completed according to Global Pharmacovigilance (GPV) processes and timelines
• Present drug safety update at monthly medical meeting as required
• Manage all MEGS/ TPS requests to agreed timelines and ensure adherence to ABPI and IPHA Codes of Practice
• Record, track and file all requests to completion.
• Compile UK Annual declaration for ToV ensuring a high level of accuracy is maintained
• Provide a high level of support to the Medical Director and general administrative duties for the Medical Affairs Department; provision of hospitality/ hotels/taxi services for external customers; assistance with Medical Department reports.
• Keep accurate files and audit trails
• Maintain and adapt processes to ensure efficiency and accuracy
• Manage all aspects of medical archiving for UK RCU
• Trained on applicable systems including the TrackWise, eGSOP, LifeSphere, electronic copy approval system, TRACE and E1 system
• Up-to-date knowledge of applicable Norgine SOPs and guidelines as well as relevant industry guidelines/ regulations

Pharmacovigilance activities

• Identify and report adverse events and product quality complaints within reporting timelines
• Ensure that any follow up information related to an adverse event is completed according to Global Pharmacovigilance (GPV) processes and timelines
• Present drug safety update at monthly medical meeting as required

MEGS, TPS and ToV

• Manage all MEGS/ TPS requests to agreed timelines and ensure adherence to ABPI and IPHA Codes of Practice
• Record, track and file all requests to completion.

Job Rewards and Benefits