Novartis Hiring Safety Writer - Aggregate Reporting (AR) Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree Apply Now
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.
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
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