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Safety Surveillance Adviser I

2+ years
Not Disclosed
10 Jan. 3, 2025
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

Title: Safety Surveillance Adviser – Pharmacovigilance
Location: Bangalore, India
Job Category: Regulatory Affairs & Safety, Pharmacovigilance
Department: Global Safety - Global Business Services (GS-GBS)

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About the Department:

The Global Safety - Global Business Services (GS-GBS) department was established in 2010 to handle safety case processing, including medical review, safety reporting, and signal detection activities. The team ensures compliance with safety regulations from multiple sources like clinical trials, literature, and spontaneous reports, while providing proactive safety communication and training.


The Position:

As a Safety Surveillance Adviser, you will play a critical role in establishing the safety profile of Novo Nordisk’s products throughout their lifecycle. This includes pre-approval and post-approval phases of product safety surveillance, and communicating drug safety issues both internally and to health authorities (HAs). You will chair the cross-functional safety committee, presenting ongoing safety surveillance analysis to guide product safety decisions. Key responsibilities include managing safety sections of the Company Core Data Sheet (CCDS), preparing safety reports, and providing input on clinical development plans, protocols, and risk management plans.

Key Responsibilities:

  • Act as the owner of safety sections for the Company Core Data Sheet (CCDS) and maintain labeling for marketed products.
  • Prepare key safety documents such as Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
  • Provide safety input during the development phase, including for Product Development Plans, Clinical Trial Protocols, Investigator’s Brochures, and Risk Management Plans.
  • Participate in project and trial teams, ensuring proactive safety communication.
  • Address safety inquiries from Health Authorities and Ethics Committees regarding protocols and patient safety.

Qualifications:

  • Education: Master’s degree in Medicine or MD post-MBBS preferred.
  • Experience: Experience in Signal Management, Aggregate Management, and ICSR.
  • Skills:
    • Proficient in Microsoft Office tools (Outlook, Word, Excel, PowerPoint).
    • Fluent in both written and spoken English.
    • Analytical, organized, and quality-driven mindset.
    • Excellent communication skills with the ability to work independently and within cross-functional teams.
    • Flexibility to adapt to changes in a dynamic environment.

Working at Novo Nordisk:

Novo Nordisk is a leading global healthcare company committed to defeating chronic diseases. With a strong legacy in diabetes care, we are expanding rapidly and positively impacting millions of patients worldwide. At Novo Nordisk, we value the unique perspectives and skills of our diverse employees, working together toward a collective goal of improving lives.


Application Deadline: 5th January 2025
To apply, please upload your CV and motivational letter online.