Novartis Pharma Safety Writer Vacancy - Candidates Apply Online

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)

Id: 345990BR

Eligibility Criteria:

• 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.

Apply Online

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