Clinical Scientific Expert I

1+ years

Not Disclosed

Hyderabad

15 June 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary:

Novartis is seeking individuals to join its Global Drug Development (GDD) team, comprising 150 clinical scientific experts globally. The team ensures the highest quality of clinical trial data and regulatory reports across all disease areas, supporting Novartis in reimagining medicine for patients worldwide.

About the Role:

Major Accountabilities:

Ensure high-quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT).
Perform thorough clinical data review and identify insights through patient-level review and trends analysis, supporting Interim Analysis, Database, and Post Lock activities.
Contribute to the development of the Data Review/Quality Plan (DRP/DQP) and data review strategy.
Support the development of study-level documents and contribute to pharmacovigilance activities if required.
Produce training materials and provide training to iCTT.

Role Requirement:

Education: Advanced degree in life sciences/healthcare (or clinically relevant degree) required.
Experience: >1 year experience in pharmaceutical industry/clinical research organization preferred.
Skills: Strong analytical skills, knowledge of clinical trial design, statistical analysis, and regulatory processes. Fluent in English (oral and written).

Why Novartis?

Novartis aims to improve and extend people's lives through innovative science and digital innovation. The company fosters a diverse, equitable, and inclusive environment, inspiring new ways of working. Novartis encourages collaboration and offers opportunities for personal and professional growth.

Join Our Novartis Network:

Stay connected with Novartis and explore career opportunities by joining the Novartis Network.

Division:

Development

Business Unit:

Pharmaceuticals

Location:

India, 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:

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