Vigilance Compliance Excellence Expert

328765BR
Sep 30, 2021
India

Job Description

100+ initiatives in Operational Excellence! We are continuously improving pharmacovigilance processes and deliverables across Chief Medical Office and Patient Safety, ensuring adherence to Novartis Policies and compliance with international regulations, supporting the organizational strategy while striving for an enhanced productivity, quality and better patient outcomes.

Your responsibilities include, but are not limited to:

• To support management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products
• Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
• Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
• Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments
• Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
• Work with other local/global PV associates to ensure accurate evaluation of safety data. Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third-party contractor, if applicable.
• Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
• Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.

Diversity & Inclusion / EEO

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

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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Global Drug Development
CMO & PATIENT SAFETY GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
328765BR

Vigilance Compliance Excellence Expert

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