Global Medical Information and Library Services
vor 1 Tag
CSL Vifor, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company are experiencing rapid growth due to pipeline realization, optimization and global partnership alliances. As such the need has arisen for a Global Medical Information and Library Services Manager based in our Headquarters in Glattbrugg, Switzerland. In this global role you will be responsible for products across the portfolio and a key orchestrator of high quality responses to patients and Health Care Professionals (HCP’s).
This strategic position will require excellent stakeholder management with local MI affiliates, vendors and commercial in
- and out-licencing partners. You will have a background in either local or global Medical Information and have a passion and interest in ensuring that medical compliance is strictly adhered to for the company to meet commercial objectives.
Main Accountabilities
- Ensure up-to-date, high quality and relevant medical, technical and pharmaceutical information on Vifor Pharma designated products to external and internal customers.
- Develop in depth knowledge on processes and regulations pertained to Medical Information.
- Awareness of the legal and ethical issues affecting the provision of medical information in the different markets serviced
- Management of the off-shored Medical Information vendor and oversee development of Global Key Information Documents (GKIDs) and escalated enquiries.
- Liaise with affiliate and partner Medical Information staff and support them with content and processes.
- Assist the medical information team to monitor medinfo relevant CAPA’s both with internal stakeholders and partners.
- Management of the off-shored library services team and take charge of Library Service operations.
Key Measures of Success
- Timely resolution of medical enquiries in support of Vifor portfolio.
- Quality, consistency and effective management of medical information enquiries.
- Maintenance of a sound repository of standard response letters for the products responsible.
- Compliance with regulations, Codes, Policies, Instructions and service level agreements.
- Regular analysis of MI data on IRMS to generate MI trends and report on the same.
- Quality and compliance of Library Services operations.
Tasks
- Work with Global Head Medical Information, cross-functional experts and vendors to ensure consistency and high quality of responses to enquires
- Support and liaise with Vifor Pharma staff, affiliates and partners to ensure high quality responses to customers globally
- Oversee the development key information documents (KIDs) and ensure all documents are up to date, scientifically accurate, fully referenced and compliant with global and as applicable local medical information regulations
- Work closely with the Pharmacovigilance Department to ensure an ongoing collaboration within their processes (e.g. identification and referral of safety related enquiries)
- Establish and regularly update relevant information sources such as databases (IRMS), factsheets (Allergen/trace elements certificates) and other technical information
- Management and administration of the medical information system to ensure compliance with Vifor Pharma's current policies and instructions
- Ensure affiliate medical departments are trained on and are compliant with the global medical information procedural documents, including use of the medical information system
- Contribute to continuous improvement of medical information processes, in line with customer expectations and business needs
- Support the timely management of contracts with different vendors including diligent budget tracking
- Management of a library or bibliography service for the provision of literature support for Vifor Pharma
- Manage the copyright approval process through the Library Services and provide copyright guidance to employees at Vifor Pharma.
- Management of vendor contracts specific to medical information
- Be cognizant of changes to medical information regulations
Minimum Requirements
- Degree in science, pharmacy, pharmacology or related field
- At least 2 years previous experience in medical information either within an affiliate or at HQ level
- Demonstrated ability to accurately and effectively evaluate medical scientific literature.
- Professional level in English, both in oral and written communications
- Experience of working in a customer focused environment
- Awareness of the legal and ethical issues affecting the provision of information in the different markets served
Preferred Requirements
- Doctoral level degree (MD, PhD or PharmD)
- Four years’ experience in Medical Information/Medical Affairs preferably at affiliate as well as at HQ level
- Previous experience in medical writing and database administration
- Ability to work in a cross-functional matrix environment
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