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Safety Operations Specialist I

6+ years
Not Disclosed
10 Feb. 24, 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

Job Title: Safety Operations Specialist I
Location: Bangalore, India
Company: Novo Nordisk
Department: Global Safety – Global Business Services

About the Position:

Novo Nordisk is seeking a Safety Operations Specialist I to join their Global Safety – Global Business Services team. This role is ideal for professionals passionate about ensuring the safety of medicinal products, with extensive experience in pharmacovigilance and regulatory compliance. The individual in this position will support safety deliverables, handle adverse events, and ensure fulfillment of global regulatory requirements.

Key Responsibilities:

  • Safety Case Processing: Handle safety information, including adverse events, ensuring global regulatory compliance.

  • Project Leadership: Lead cross-functional projects, define project scope, goals, and deliverables.

  • Deviation & Change Management: Own deviation/change requests, prepare reports, facilitate investigations, and implement corrective actions.

  • Audit & Inspection Support: Review safety data, participate in audits, and present global safety processes.

  • Regulatory Collaboration: Work with affiliates to support the implementation of new regulatory requirements.

Qualifications:

  • Educational Qualification: Graduation and/or post-graduation in life sciences.

  • Experience: Minimum of 6 years of relevant experience in pharmacovigilance.

  • Knowledge: Deep understanding of pharmacovigilance principles, GxP requirements, scientific regulations/guidelines.

  • Skills: Ability to lead projects, experience in business process improvements, and fluency in English (written and spoken).

About Novo Nordisk:

Novo Nordisk is a global healthcare leader focused on driving change to defeat chronic diseases like diabetes. With a legacy spanning over 100 years, Novo Nordisk reaches millions of patients worldwide. The company values the diversity of its employees, fostering an inclusive culture that celebrates diverse perspectives.

Why Join Novo Nordisk?

  • Work for a company with a strong legacy and a global reach.

  • Be part of a collaborative and inclusive work environment.

  • Contribute to life-changing work for patients worldwide.

Deadline for Application: March 10, 2025

Apply Now!

For further information, visit Novo Nordisk's official website or follow the application instructions on the career portal.

Note on Fraudulent Job Offers:

Novo Nordisk has warned applicants about fraudulent job offers. The company does not charge fees or request funds during the recruitment process. Always apply directly via their official channels.