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Safety Surveillance Adviser I

2+ years
Not Disclosed
10 Nov. 22, 2024
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

About Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to combat serious chronic diseases. With a strong presence in diabetes care, we are expanding rapidly and impacting over 40 million patients daily. Our success has made us one of the 20 most valuable companies globally by market capitalization.

At Novo Nordisk, we value the unique skills and perspectives of our employees and are committed to fostering a culture of collaboration and continuous improvement. Join us in our mission to make a life-changing impact. Together, we go further. Together, we’re life-changing.


Department Overview: Global Safety - Global Business Services (GS-GBS)

The Global Safety - Global Business Services (GS-GBS) department, established in 2010, serves as a central hub for safety case processing. GS-GBS handles case processing from a variety of sources, including spontaneous reports, literature, solicited cases, and clinical trials. The team is involved in key activities such as:

  • Case processing and medical review
  • Safety report submission
  • Signal detection and risk mitigation
  • Quality control of Individual Case Safety Reports (ICSR)
  • Training coordination
  • Medical literature surveillance

GS-GBS plays a critical role in ensuring the safety of Novo Nordisk’s products throughout their lifecycle.


The Role: Safety Surveillance Adviser

Location: Global
Department: Global Safety - Global Business Services (GS-GBS)

As a Safety Surveillance Adviser, you will be responsible for establishing and maintaining the safety profile of Novo Nordisk products throughout their development and post-marketing phases. Your role will involve performing ongoing safety surveillance of products, preparing safety documentation, and ensuring regulatory compliance with Health Authorities (HAs).

Key Responsibilities

  • Safety Labeling Management:
    • Own and manage safety sections of the Company Core Data Sheet (CCDS) for developmental products and ensure the labelling for marketed products is up to date.
    • Review and provide safety input during labelling change requests (LCRs).
  • Safety Reporting:
    • Prepare Development Safety Update Reports (DSURs), Periodical Safety Update Reports (PSURs), Risk Management Plans (RMPs), and SUSAR reports for clinical trials.
    • Respond to safety-related queries from HAs and internal stakeholders.
  • Safety Communications:
    • Participate in project and trial teams to provide proactive safety communication.
    • Conduct investigator training as needed.
  • Regulatory Communication:
    • Provide safety input for documents such as Product Development Plans (PDPs), clinical trial protocols, Investigator's Brochures (IB), and safety summaries for publications.
    • Address inquiries from Ethics Committees (ECs) and Data Monitoring Committees (DMCs).

Qualifications

  • Education:

    • A Master’s in Medicine or MD post-MBBS is preferred.
  • Experience:

    • Experience in Signal Management, Aggregate Management, and ICSR (Individual Case Safety Reports) is essential.
    • Experience in safety surveillance and regulatory reporting is preferred.
  • Skills:

    • Proficient user of Microsoft Office (Word, Excel, Outlook, PowerPoint).
    • Fluent in written and spoken English.
    • Analytical mindset with a quality-oriented approach.
    • Strong communication skills (verbal and written).
    • Proactive, well-organized, and adaptable to change.
    • A strong team player with cross-cultural awareness.

Working at Novo Nordisk

At Novo Nordisk, we are committed to building an inclusive culture where everyone can thrive. We recognize that to be the best company for the world, we need a diverse and talented team that brings unique perspectives to the table. We are dedicated to providing equal opportunities for all our job applicants and employees.

Together, we are life-changing.


Application Process

To submit your application, please upload your CV and motivational letter through the online application portal.

Application Deadline: 30th November 2024


Important Disclaimer

We have recently become aware of fraudulent job offers that are being made in Novo Nordisk's name. These fraudulent offers may ask for personal information or payment for equipment or training. Novo Nordisk will never ask for money as part of the recruitment process.


Equal Opportunity Commitment

At Novo Nordisk, we are committed to creating an inclusive culture that celebrates diversity and provides equal opportunity for all job applicants. We value the diverse perspectives and contributions of our employees, which enables us to make a greater impact in the world.