Career as CDS Manager in Global Drug Development @ Novartis
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : CDS Manager
The CDS & SD Manager evaluates Safety Signals from various sources and keeps the core safety information up-to-date (prepares and reviews CDSs) with current scientific knowledge, including assessments and recommendations made public by regulatory authorities.
• Ensures patient safety through timely and adequate updates of the core safety in-formation of marketed products.
• Tracks signals in the signal management tracking system, and evaluates line listings and safety information in scientific literature, including reference product information and regulatory authority communication.
• Works closely with affiliates to harmonize labelling, periodically collect compliance information and prepare management reports.
• Prepares, and drives timeliness, volume and high quality of CDS documents
•Assists in managing 3rd party providers for the production of CDS and other documents.
• Prepares data packages required by 3rd party providers. Reviews and qualifies CDSs deliveries from providers.
• Quality of work delivered (attention to details, thoroughness, medical sound judgment, and writing)
• Timeliness of deliverables according to established directives
• Compliance with Internal and external regulations and procedures
• High level of independence
Health Care Professional with labeling and ideally regulatory background, i.e., Pharmacist, PharmD, MD and equivalent Fluency in English, including medical / pharmaceutical terminology. Knowledge of other languages desirable and necessary Established knowledge of, and experience in the EU drug regulatory environment and drug approval procedures Familiarity with EU signal sources / regulatory bodies At least 1 year of experience in drug safety/development or closely related areas of responsibility Experience of safety document writing Good negotiation, proactive and performance oriented, project management and communication skills Fluency in EU and US regulation
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