Safety Case Expert

4 days ago

Hyderabad Telangana, India Novartis Full time

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.
- 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**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- 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.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

Imagine what you could do here at Novartis

**Division**

Global Drug Development

**Business Unit**

Patient Safety & Pharmacovigilance

**Country**

India

**Work Location**

Hyderabad, AP

**Company/Legal Entity**

Nov Hltcr Shared Services Ind

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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