Safety Writer - Aggregate Reporting (AR)
Hyderabad, AP, India
5d ago

Job Description

1.Support / lead end-to-end preparation of aggregate safety reports. 2.Support coordination with GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.

3.Retrieve and analyze the safety data from global safety database and ensure adequate presentation in the ARs. 4.Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all HA requirements.

5.Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.

6.Support independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards.

7.Adhere to good documentation practices to ensure audit / inspection readiness. 8.Support projects related to operational excellence (including testing of safety systems / IT application) and process improvements according to internal and externals drivers 9.

Support Health Authority inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings.

10.Responsible to be informed with the current global PV regulatory requirements.

Minimum requirements

Graduate / Post Graduate / Doctorate degree in Life Sciences / Pharmacy / Medical Sciences or equivalent degree Fluency in English.

Knoweldge of other languages 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 an global environment and across line functions
  • Strong organizational and project management skills, with an ability to lead work groups
  • Apply
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