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 capitalization and sales.
Job ID : 227230BR
Position Title : CDS Manager
Division : Global Drug Development
Business Unit : CMO & PATIENT SAFETY GDD
Country : India
Work Location :Â Hyderabad
Company/Legal Entity : Nov Hltcr Shared Services Ind
Functional Area : Research & Development
Job Description:
- 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.
Qualifications:Â
• 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
• 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