| || 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 judg-ment, 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 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