Safety Operations Specialist I

6+ years

Not Disclosed

Bangalore

10 Jan. 13, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

Safety Operations Specialist I – Global Safety, Global Business Services (GS-GBS)

Location: Novo Nordisk Global Business Services, Bangalore, India
Application Deadline: 24th January 2025

Do You Have a Passion for Pharmacovigilance?

If ensuring the safety of medicinal products and maintaining regulatory compliance excites you, this role is a fantastic opportunity. Join the Global Safety team at Novo Nordisk in Bangalore to drive impactful change and make a difference.

The Position

As a Safety Operations Specialist I, you will:

Handle adverse events and other safety information, ensuring compliance with global regulatory requirements.
Lead cross-functional projects by defining scope, goals, deliverables, and stakeholder involvement.
Act as the owner for deviations and change requests, facilitating root cause analysis and implementing corrective/preventive actions.
Present safety data and processes in global audits and inspections.
Collaborate with global affiliates to implement new processes and meet regulatory demands.

Qualifications

Education:

Graduation/post-graduation in Life Sciences.

Experience:

Minimum 6 years in pharmacovigilance, with extensive knowledge of safety information handling.
Expertise in studying and implementing scientific regulations and guidelines.
Professional experience in training and supporting diverse groups.
Proven history of driving business process improvements in international settings.

Skills:

In-depth understanding of pharmacovigilance principles, GxP requirements, and pharmaceutical operations.
Strong communication and project management abilities.
Fluency in written and spoken English.

About the Department

The Global Safety - Global Business Services (GS-GBS) team, established in 2010, serves as a key hub for safety case processing.

Core Activities:

Managing safety case processing from diverse sources (e.g., spontaneous reports, literature, clinical trials).
Quality control of individual case safety reports (ICSR).
Safety report submission, IT quality assurance, and literature surveillance.
ARGUS configuration and maintenance.

Working at Novo Nordisk

Novo Nordisk is a global healthcare leader with a century-long legacy of driving transformative change to combat chronic diseases. Serving over 40 million patients daily, our strength lies in collaboration among 63,000+ employees worldwide.

Why Join Us?

Be part of a diverse, inclusive culture that celebrates unique perspectives and backgrounds.
Contribute to meaningful work that impacts millions of lives globally.
Experience a work environment committed to nurturing talent and fostering growth.

Together, we’re life-changing.

How to Apply

Submit your application by uploading your CV online.

Apply Now: Submit Your Application Here
Deadline: 24th January 2025

Disclaimer

Beware of fraudulent job offers. Novo Nordisk does not request personal information, funds, or equipment purchases during the recruitment process.

We are committed to an inclusive and fair recruitment process, aspiring to be the best company for the world.

Join us and make an impact—together, we’re life-changing.

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