Safety Surveillance Adviser I

0-2 years

Not Disclosed

Bangalore

10 Jan. 13, 2025

Job Description

Job Type: Full Time Education: MBBS/MD 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 Surveillance Adviser – Global Safety, Global Business Services (GS-GBS)

Location: Novo Nordisk Global Safety Hub
Application Deadline: 24th January 2025

Are You Motivated by Challenges in a Dynamic Environment?

If you thrive in a setting where collaboration with key stakeholders and strategic alignment is critical, and possess a can-do attitude with a focus on continuous improvement, this role may be for you. Join our growing team and make a difference in an international setting.

The Position

As a Safety Surveillance Adviser, you will play a vital role in ensuring patient safety throughout the lifecycle of Novo Nordisk (NN) products. This includes:

Product Safety Profile and Labelling:
- Establish and maintain product safety profiles during development.
- Oversee labelling updates for marketed products and act as a reviewer for Labelling Change Requests (LCRs).
- Serve as the owner of the safety sections in the evolving Company Core Data Sheet (CCDS).
Safety Documentation:
- Author sections of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs).
- Respond to regulatory and internal safety-related inquiries.
Clinical Trial Safety:
- Provide safety input for protocols, trial outlines, investigator brochures (IB), and integrated safety summaries.
- Ensure the safety aspects of clinical trials align with global standards.
Cross-Functional Safety Committees:
- Lead NN cross-functional safety committees, presenting safety analyses to guide decisions.
- Collaborate on risk management and proactively address safety concerns.
Stakeholder Engagement:
- Engage with regulatory authorities (HAs), ethics committees, and data monitoring committees (DMCs).
- Conduct investigator training and support internal and external stakeholders with safety communication.

Qualifications

Educational Requirements:

Master’s in Medicine or an MD post-MBBS graduate is preferred.

Experience:

Proficiency in signal management, aggregate management, and Individual Case Safety Reports (ICSRs).

Skills:

Analytical mindset with professional authority.
Strong communication skills, both written and verbal, in English.
Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
Quality-driven, well-organized, and excellence-oriented.
Flexible team player with cross-cultural awareness.

Attributes:

Curious and proactive in seeking improvement opportunities.
Resilient and adaptable to change in a dynamic environment.
Able to prioritize and meet deliverables efficiently.

About the Department

Global Safety - Global Business Services (GS-GBS), established in 2010, is a hub for safety case processing. Our responsibilities include:

Case processing from multiple sources, including clinical trials and literature.
Signal detection and risk mitigation.
Training coordination, report submissions, and quality control.

Working at Novo Nordisk

Novo Nordisk is a global leader in healthcare with a century-long commitment to improving lives. Serving over 40 million patients daily, our success stems from the collaboration and potential of 63,000 employees worldwide.

We prioritize inclusivity, diversity, and employee growth, offering a work culture that celebrates unique perspectives and backgrounds. At Novo Nordisk, you’ll contribute to something bigger—together, we’re life-changing.

Contact and Application Details

Apply Online: Upload your CV and motivational letter via our application portal.
Deadline: 24th January 2025.

Disclaimer

Be cautious of fraudulent job offers claiming to be from Novo Nordisk. We do not request fees, funds, or personal information during the recruitment process.

Novo Nordisk is committed to equality of opportunity and an inclusive recruitment process. We aspire to be not just the best company in the world but the best company for the world.

Join us in changing lives—together, we’re life-changing.

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Safety Surveillance Adviser I

Job Description

Safety Surveillance Adviser – Global Safety, Global Business Services (GS-GBS)

Are You Motivated by Challenges in a Dynamic Environment?

The Position

Qualifications

About the Department

Working at Novo Nordisk

Contact and Application Details

Disclaimer

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