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Senior Drug Safety Associate

4+ years
Not Disclosed
10 July 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Senior Drug Safety Associate – Novo Nordisk, Bangalore

Location: Bangalore, Karnataka, India
Employment Type: Full-time
Salary/Compensation: Not mentioned


Job Summary

Novo Nordisk is seeking a Senior Drug Safety Associate to manage serious and non-serious adverse event reports across clinical and post-marketing settings. The role involves medical evaluation, MedDRA coding, ICSR processing, and regulatory compliance while ensuring high-quality safety data. This is an excellent opportunity to work in a global pharmacovigilance team with a focus on patient safety and continuous improvement.


Responsibilities

  • Conduct medical evaluation, coding, and case processing of serious and non-serious adverse events in compliance with GxP and PV regulations.

  • Manage initial case triage, data entry, and quality review of ICSRs using Argus safety database.

  • Collaborate with global affiliates and internal teams to clarify safety data and manage follow-ups.

  • Participate in literature surveillance activities and safety reporting.

  • Support system optimization, data retrieval, and custom reporting for safety operations.

  • Mentor and train colleagues, contributing to continuous process improvements.

  • Ensure timely submissions of safety reports and compliance with regulatory guidelines.


Required Skills & Qualifications

  • Graduation or post-graduation in Life Sciences, Pharmacy, Medicine, Biotechnology, or Nursing.

  • Minimum 4 years of experience in ICSR processing and pharmacovigilance.

  • Hands-on experience with Argus safety database and MedDRA coding.

  • Strong understanding of pharmacovigilance processes, GxP, GDPR, and regulatory requirements.

  • Proficiency in MS Office (Word, Excel, Outlook, PowerPoint).

  • Excellent written and verbal communication skills.

  • Experience in mentoring, training, and quality trend analysis is an advantage.


Perks & Benefits

  • Work with a globally recognized healthcare company impacting 40+ million patient lives daily.

  • Exposure to global pharmacovigilance operations and cutting-edge safety monitoring.

  • Collaborative and diverse workplace with continuous career growth opportunities.

  • Competitive benefits and employee-focused policies.


Company Description

Novo Nordisk is a global leader in healthcare with over 100 years of innovation in chronic disease management. With 72,000+ employees worldwide, Novo Nordisk is committed to advancing diabetes care, obesity management, and rare disease therapies while driving global health transformations.


Work Mode: On-site (Bangalore, India)


Call-to-Action

Advance your career in pharmacovigilance with Novo Nordisk. Apply now to join our Senior Drug Safety Associate team in Bangalore and make a global impact on patient safety.