As Medical Information Manager, you will be responsible to manage medical and scientific enquiries regarding the Novartis product portfolio. You will be responsible for the provision of timely, accurate and balanced medical/scientific information to external and internal customers. You will be the main point of contact from the medical team for the established products which are not in promotion anymore. You work closely together with the Medical Affairs teams and supporting the early portfolio teams with literature searches, creating Patient Journeys and defining data gaps, contributing to execution of the early launch strategies.
Your responsibilities include, but are not limited to:
• Receive enquiries from external stakeholders (e.g. physicians, pharmacists, patients) and internal departments (e.g. Regulatory Affairs, Sales, Marketing, Value& Access) regarding established products and responds to enquiries by providing answers directly, or by obtaining necessary information from the appropriate data source. Reporting of technical complaints / adverse events / special case scenarios related to the client products within 24 hours of receipt
• Manage the local Medical Information databases and create, review as well as update standard responses on a regular basis. Provide reports for reconciliation with Quality Assurance (QA) and Patient Safety departments.
• Coordinate training activities for Medical Information databases and educates other associates on how to respond to medical enquiries
• Support management of operational processes in ensuring compliance with the client global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products
• Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, postmarketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
• Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
• Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments
• Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
• Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
• Management and maintenance all relevant assigned PVO databases, if applicable.
• MD, PharmD or biomedical education. PhD in life Sciences with solid medical/technical background
• English: fluent spoken & written
• Dutch: fluent spoken & written
• Pharmaceutical industry experience
• Strong medical and scientific bases
• Good planning and organizational skills
• Strong entrepreneurial mindset
• Strong communication skills and customer orientation
• Good medical and scientific writing skills
• Experience in handling RMP materials is a pre
• Experience in working on development of early portfolio
products is a pre.