Work as CDS Manager in Global Drug Development at Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : CDS Manager

Job Description:
• Ensures patient safety through timely and adequate updates of the core safety information 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

 

Educational background and experience:
• Health Care Professional with regulatory background, i.e., Pharmacist, PharmD, MD and equivalent
• Experience in safety document writing, labelling and DRA activities for >5 years.
• Established knowledge of, and experience in the EU drug regulatory environment and drug approval procedures
• Familiarity with EU signal sources / regulatory bodies
• Fluency in English, including medical / pharmaceutical terminology. Knowledge of other languages desirable and necessary
• 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

Additional Information:
Experience: >5 years
Qualification: Pharmacist, PharmD, MD
Requisition ID: 216115BR
Location: Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Human Resources
End Date: 10th July, 2017

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