Instagram
youtube
Facebook

Associate Safety Operations Adviser

1+ 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 Operations Adviser (Pharmacovigilance)
Location: Bangalore, India
Department: Global Safety

About Novo Nordisk:

Novo Nordisk is a global leader in healthcare, committed to improving the lives of people with chronic diseases. Our strong legacy in diabetes care is expanding worldwide, impacting millions of patients every day. At Novo Nordisk, we value collaboration, diversity, and innovative thinking. Join us in our mission to defeat serious chronic diseases.

The Position:

The Safety Operations Adviser will play a vital role in ensuring the safety and quality of Novo Nordisk’s clinical and marketed products. This role involves collecting, evaluating, and reporting adverse events (AEs) to global regulatory authorities. The ideal candidate will have a strong background in pharmacovigilance, clinical development, and regulatory requirements, ensuring accurate reporting and medical evaluation of safety information.

Key Responsibilities:

  • Adverse Event Management: Evaluate and report safety information related to adverse events from clinical trials, named patient supplies, and post-marketing use of Novo Nordisk products.
  • Medical Evaluation: Assess serious adverse events (SAEs) for causal relationships and provide medical evaluations.
  • Reporting: Ensure compliance with global regulatory requirements by reporting AEs to the relevant authorities in a timely manner.
  • Collaboration: Work closely with cross-functional teams including Clinical Development, Global Safety, Data Management, and external collaborators to ensure accurate AE handling.
  • Protocol Review: Review clinical protocols to ensure the collection of safety data aligns with regulatory guidelines.
  • MedDRA Coding: Ensure consistent and accurate coding of adverse events using MedDRA across projects, products, and countries.
  • Training & Development: Participate in training and meetings to stay current on industry standards, regulatory guidelines, and new developments in pharmacovigilance.
  • Compliance: Ensure all tasks are completed in compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards.

Qualifications:

  • Education: Postgraduate MD / MBBS with 1-2 years of relevant pharmacovigilance experience.
  • Experience: Preferably 0-1 years of experience in the pharmaceutical industry with a focus on pharmacovigilance.
  • Knowledge:
    • Strong understanding of clinical pharmacology, diseases, and treatment complications.
    • Good knowledge of pharmacovigilance, clinical development, and regulatory requirements.
    • Proficiency in database management and medical terminology.
  • Skills:
    • Fluent in both written and spoken English.
    • Strong planning, coordination, and communication skills.
    • Ability to work independently and manage projects in a collaborative environment.
    • Analytical and organized with a flexible mindset.

Working at Novo Nordisk:

At Novo Nordisk, we’re driven by our purpose to help people live independent lives, free from chronic disease. Join a team that values diversity, collaboration, and a shared commitment to life-changing healthcare.

Application Process:

To apply, please upload your CV online through the application portal.

Deadline: Please submit your application by January 5, 2025.

Novo Nordisk promotes an inclusive recruitment process and provides equal opportunity for all candidates.