Novartis
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market cap and sales.
Job Title: CDS Manager
Job Description: • 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.
Qualifications: Health Care Professional with labelling 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
