CDS Manager Position Vacant for Pharma Candidates @ Novartis

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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

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