VACANCIES FOR THE POST OF CDS MANAGER AT NOVARTIS, HYDERABAD

Job IDs:                             217166BR; 227230BR

Position Title:                   CDS Manager

Division:                            Global Drug Development

Business Unit:                   CMO & PATIENT SAFETY GDD

Country:                            India

Work Location:                 Hyderabad

Company/Legal Entity:    Nov Hltcr Shared Services Ind

Functional Area:               Research & Development

Job Type:                            Full Time

Employment Type:            Regular

Job Description: 

ü 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. 

Minimum requirements:

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

Educational requirements:   

ü Health Care Professional with labelling 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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