28 May, 2022
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.
- 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