Novartis Hiring Safety Writer – Aggregate Reporting (AR)

Novartis Hiring Safety Writer – Aggregate Reporting (AR)

28 May, 2022

Job Description

2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety.

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 received, analyzed and incorporated into ARs as per the regulatory requirements.
  • Retrieve and analyze the safety data from global safety database and ensure adequate presentation in the ARs.
  • Ensure a comprehensive and consistent aggregate analysis 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.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

  • Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree Fluency in English. Knowledge 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 through this Link

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