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Safety Surveillance Adviser I

2+ years
Not Disclosed
10 Dec. 18, 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, 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

Job Title: Safety Surveillance Adviser
Location: Bangalore, India
Department: Global Safety - Global Business Services (GS-GBS)

About Novo Nordisk:

Novo Nordisk is a global healthcare leader with over a century of success in developing life-changing therapies for chronic diseases. We are expanding rapidly, impacting millions of lives worldwide. Our success is driven by the diverse skills and perspectives of our employees, and we are committed to fostering a collaborative, inclusive environment. Join us in our mission to defeat chronic diseases and improve patient lives.

The Position:

As a Safety Surveillance Adviser, you will be responsible for establishing and maintaining the safety profile of Novo Nordisk products during their development and after market approval. You will oversee ongoing safety surveillance, analyzing safety data from global sources, and ensuring effective communication of drug safety issues internally and to regulatory authorities.

You will lead the cross-functional safety committee, presenting safety analysis and results, and making recommendations based on ongoing surveillance. Your role will also involve ensuring patient safety in clinical trials and managing the safety sections of key documents such as Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs).

Key Responsibilities:

  • Safety Profile Management: Oversee and maintain the safety profile of products in the development phase and for marketed products. Ensure up-to-date labelling for new and marketed products.
  • Report Preparation: Author relevant sections of DSURs, SUSAR reports, PSURs, and Risk Management Plans (RMPs) as required by health authorities.
  • Cross-Functional Collaboration: Lead safety discussions in project and clinical trial teams, ensuring safety issues are addressed, and provide safety input to documents like the Product Development Plan (PDP), Investigator’s Brochure (IB), and clinical trial protocols.
  • Regulatory Communication: Respond to safety-related inquiries from health authorities (HAs), Ethics Committees (ECs), and internal stakeholders.
  • Signal Detection: Monitor and assess adverse events (AEs) and potential safety signals from clinical trials and post-market data.
  • Training and Support: Provide safety-related training to investigators and ensure compliance with safety reporting procedures.
  • Documentation: Ensure thorough safety documentation, including preparing reports and submitting information to health authorities and regulatory bodies.

Qualifications:

  • Education: Master's in Medicine or MD post MBBS is preferred.
  • Experience: Experience in Signal Management, Aggregate Management, and Individual Case Safety Reports (ICSRs) is highly desirable.
  • Skills:
    • Strong proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
    • Fluent in written and spoken English.
    • Analytical mindset with a proactive, organized approach.
    • Strong communicator with the ability to present safety data effectively.
    • Excellent planning, coordination, and project management skills.
    • Flexible and service-minded, with cross-cultural awareness.
    • Ability to thrive in a dynamic, evolving environment.

About the Department:

Global Safety - Global Business Services (GS-GBS) is a central hub for safety case processing. Our team manages case processing, signal detection, risk mitigation activities, safety report submissions, and more. We are dedicated to ensuring the safety of Novo Nordisk products through collaboration, training, and a high standard of quality assurance.

Working at Novo Nordisk:

Novo Nordisk’s success is driven by our people, and we’re dedicated to creating an inclusive culture that celebrates diversity. Our global team is united in the effort to improve patient lives. Together, we go further. Together, we’re life-changing.

Application Process:

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

Deadline: January 5, 2025

Novo Nordisk is committed to an inclusive recruitment process and provides equal opportunity for all candidates.