Job ID 217165BR
Position
Title CDS Manager
Division Global Drug Development
Business
Unit CMO & PATIENT SAFETY GDD
Country India
Work
Location Hyderabad
Company/Legal
Entity Novartis
Healthcare Shared Services, India
Functional
Area Research & Development
Job Type Full Time
Employment
Type Regular
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.
ü Ensures patient safety through timely and adequate
updates of the core safety in-formation of marketed products.
ü 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.
ü Works closely with affiliates to harmonize labelling,
periodically collect compliance information and prepare management
reports.
ü Prepares, and drives timeliness, volume and high quality
of CDS documents
ü Assists in managing 3rd party providers for the
production of CDS and other documents.
ü Prepares data packages required by 3rd party providers.
Reviews and qualifies CDSs deliveries from providers.
ü Quality of work delivered (attention to details,
thoroughness, medical sound judgment, and writing)
ü Timeliness of deliverables according to established
directives
ü Compliance with Internal and external regulations and
procedures
ü High level of independence
Minimum requirements:
ü Health Care Professional with labeling and ideally
regulatory background, i.e., Pharmacist, Pharm D, MD and equivalent
ü Fluency in English, including medical/pharmaceutical
terminology.
ü Knowledge of other languages desirable and necessary
ü Established knowledge of, and experience in the EU drug
regulatory environment and drug approval procedures
ü Familiarity with EU signal sources / regulatory bodies
ü At least 1 year of experience in drug safety/development
or closely related areas of responsibility
ü Experience of safety document writing
ü Good negotiation, proactive and performance oriented,
project management and communication skills
ü Fluency in EU and US regulation
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