About the job
Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients. With the ever-evolving global regulations in the field of pharmacovigilance, with a focus on pragmatic approaches to protecting patient safety and incorporating the patient voice into the complex and evolving pharmacovigilance ecosystem. Forward-thinking safety case experts are invited to apply in Case Management Operations to facilitate effective application of new technologies and methods to streamline pharmacovigilance systems and processes to enhance protection of patient safety as products become more complex, new data sources drive new analytical techniques, regulatory requirements become more detailed, and medical product development becomes more global. As part of the Novartis Case Management Operations, this is an important role requiring your skills and application abilities to achieve operational excellence.
Your responsibilities include, but are not limited to:
- Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents and product and event coding, narrative writing and follow-up for missing or other medical important information. Including daily quality review (QR) for Individual Case Safety Reports (ICSR) to allow analysis of data entry/quality
- Support audits & inspections preparation activities and support implementation of Corrective and Preventive Actions
- Monitor metrics to ensure timely triggers for follow-up actions
- Collaborate with Trial Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.
- Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
- Support the development and testing of safety systems/IT applications and in the preparation of relevant manuals
- Work with Novartis country safety departments, License partners, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and data based.
- Lead/Support CMO&PS Operational Projects or database validation activities as required.
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. Business fluent in English (written and spoken).
- Overall experience of 2 to 4 years in in drug safety / Development or closely related areas of responsibility.
- Previous hands-on experience with data entry in safety databases including quality review. Good understanding of Clinical Databases and its set-up.
- Strong negotiation and ability to operate effectively in an global environment and across line functions
- Expertise in processing of all report types including Clinical Trial, Literature and PMS reports.
How to Apply?
Apply through below link