Novartis Pharma Safety Writer Vacancy 2022 – Apply Online
Novartis hiring a safety writer. Pharma job opening 2022. Pharmacy job 2022. B Pharma job, M Pharma job opening 2022. Ph.D. Pharmacy job opening 2022. Pharmacy job opening 2022. Safety Writer job opening 2022. Pharma job vacancy 2022. Interested and eligible candidates may apply for the job opening. Check out all the details on the same below:
Job Title: Safety Writer – Aggregate Reporting (AR)
Job Id: 345990BR
• Graduate/Post Graduate/Doctorate degree in Pharmacy/Medical Sciences or equivalent degree Fluency in English. Knowledge of other languages is desirable.
• 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility
• Preferably, at least 2 years of experience in safety/ medical/scientific/regulatory writing
• Excellent understanding of drug development process, GCP and medical terminology
• Strong negotiation and communication skills, and ability to operate effectively in a global environment and across line functions
• Strong organizational and project management skills, with an ability to lead workgroups
Your responsibilities include, but are not limited to:
• Support/lead end-to-end preparation of aggregate safety reports. Support coordination with GLFs to ensure information is received, analyzed, and incorporated into ARs as per the regulatory requirements.
• Retrieve and analyze the safety data from the global safety database and ensure adequate presentation in the ARs.
• Ensure a comprehensive and consistent aggregate analysis is performed to establish the risk-benefit profile of the product that meets all HA requirements.
• Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
• Support independent QC of ARs to ensure the information presented in AR is complete, consistent, and compliant to regulatory and Novartis standards. Adhere to good documentation practices to ensure audit/inspection readiness.
• Support projects related to operational excellence (including testing of safety systems/IT application) and process improvements according to internal and externals drivers
• Support Health Authority inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings. Responsible to be informed of the current global PV regulatory requirements.
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