Job Description
Vacancy for Safety Writer – Aggregate Reporting at Novartis.
Job Title/Position:
Safety Writer – Aggregate Reporting (AR)
Job Overview:
Job vacancy for Life Sciences, Pharmacy
What are the Key Responsibilities?
• 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.
What are the Educational Qualification(s) for this position(s)?
Graduate/Post Graduate/Doctorate degree in Life Sciences / Pharmacy/ Medical Sciences or equivalent degree Fluency in English. Knowledge of other languages desirable.
What is the Experience Required for this Job?
• 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility
What are the Preferred Skills required for this Job/Position?
• 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.
Related:
Vacancy for Regulatory Toxicologist at Syngene International Ltd
