Novartis Pharma Safety Writer Vacancy – Candidates Apply Online
Novartis pharma and chemistry job opening 2022, pharmacy job opening 2022. safety Writer – Aggregate Reporting vacancy. Candidates with pharmacy may apply for the job opening at Novartis. Pharma job opening 2022. Pharmacy job opening 2022. Check out all the details
Job Title: Safety Writer – Aggregate Reporting (AR)
• 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 work groups.
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 with the current global PV regulatory requirements.
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