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 PerformanceIndicators:

. 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

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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
No