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Associate Safety Operations Adviser

1-2 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 Operations Adviser – Pharmacovigilance
Location: Bangalore, India
Job Category: Regulatory Affairs & Safety, Pharmacovigilance
Department: Global Safety

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About the Department:

The Global Safety team in Bangalore is responsible for overseeing the safety and quality of Novo Nordisk's clinical development and marketed products. The team handles the global reporting and surveillance of adverse event reports, ensuring safety compliance for clinical and post-marketing products.


The Position:

As a Safety Operations Adviser, you will be responsible for ensuring the accurate and timely collection, medical evaluation, and reporting of adverse events (AEs) for Novo Nordisk’s pharmaceutical products. You will assess spontaneous and serious AEs from clinical trials and marketed use, ensuring compliance with global regulatory requirements. The role demands a high level of professional insight, self-reliance, and flexibility, requiring close collaboration with stakeholders both internally and externally. Additionally, you will contribute to the review and preparation of follow-up questions, perform AE coding using MedDRA, and ensure compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).

Key Responsibilities:

  • Ensure the collection, evaluation, and reporting of adverse events, ensuring alignment with global regulatory standards.
  • Medical evaluation of serious adverse events, including causal relationship assessments.
  • Conduct reviews of AE, pregnancy, and safety information forms, and ensure proper coding of AEs.
  • Participate in safety meetings, clinical protocol reviews, and contribute to project teams.
  • Supervise the reconciliation process of SAEs with clinical trial databases.
  • Ensure compliance with GCP, GMP, and other regulatory requirements.

Qualifications:

  • Education: Postgraduate MD/MBBS with 1-2 years of experience in Pharmacovigilance (preferred).
  • Experience: 0-1 years in the pharmaceutical industry.
  • Skills:
    • Strong knowledge of clinical pharmacology, diseases, and their clinical manifestations.
    • Familiarity with databases and pharmacovigilance processes.
    • Fluent in English (both written and spoken).
    • Ability to work independently and within teams.
    • Good communication, planning, and analytical skills.

Working at Novo Nordisk:

Novo Nordisk is dedicated to changing lives by developing groundbreaking treatments for chronic diseases. Our inclusive environment celebrates diversity and strives to create an atmosphere where employees thrive both professionally and personally.


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