India Job Openings

Novartis

Senior Safety Case Expert

Hyderābād

FULL TIME

August 31, 2024

Summary

Responsible to ensure case processing and ancillary activities in compliance with PS&PV business rules, standard operating procedures and regulatory requirements. Responsible for preparation and maintenance of manuals and other relevant/assigned documents Subject matter expert for cross-sub functional projects within PS&PV Lead implementation of new process and process amendments/changes

About the Role

Major Accountabilities:
Monitor all case processing related activities to facilitate oversight on External Service Providers (ESP’s) quality and compliance of deliverables

Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality. Perform Argus data entry as needed.

Perform daily quality review (QR) for Individual Case Safety Reports (ICSR) by comparing source documents and the case information entered the safety database to ensure accurate and consistent data entry/quality. Coach/Train/Mentor other team members including ESPs, as required

Lead/support the process changes according to internal and externals drivers, including development and monitoring of process related metrics

Lead the preparation and maintenance of manuals and other relevant/assigned documents

Participate in the creation and maintenance of training material and communications for Novartis and ESPs.

Act as Subject Matter Expert / consultant to PS&PV associates, Country Organizations and
other Global Line Functions on regulatory requirements and assigned business process.

Develop, contribute and maintain guidance documents including providing inputs to Vigilance Agreement (VA) and other such safety management plans

Support in audits/inspection as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings

Assess and analyze case processing related queries from Health Authorities and prepare and share the responses within the timelines.

Support in-collaboration with other functions within PS&PV to facilitate process improvements

Collaborate with Data Management team to enable reconciliation for 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.

Work with Novartis country safety departments, License partners and medical function to ensure that reports are accurately collected, evaluated and data based. Lead the testing activities for case processing related safety systems/IT applications.

Lead PS&PV Operational Projects and support high complex/critical projects or database validation activities as required.

Key Performance Indicators:

. Quality and compliance for the assigned deliverables

No critical findings from audits/inspections

Consistent demonstration of company values/behaviors

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division

Development

Business Unit

Innovative Medicines

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

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

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