Safety Operations Specialist I

Novo Nordisk

2+ years

Not Disclosed

Bangalore

10 March 19, 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
Company: Novo Nordisk
Location: Bangalore, India
Job Category: Regulatory Affairs & Safety Pharmacovigilance

Join Our Mission to Ensure Global Patient Safety

Are you passionate about pharmacovigilance and ensuring the safety of medicinal products? At Novo Nordisk, we are committed to the health and well-being of patients worldwide. We are seeking a Safety Operations Specialist I to contribute to our global safety operations and support our mission of providing high-quality healthcare. If you have extensive experience in pharmacovigilance and regulatory compliance, apply today for a life-changing career with us!

Position Overview:

As a Safety Operations Specialist I, you will be responsible for:

Safety Data Management: Handle adverse events and other safety information to meet global regulatory requirements.
Project Leadership: Lead cross-functional projects by defining scope, goals, and stakeholder mapping.
Process Improvement: Review safety data for audits and inspections, collaborate on implementing new processes based on evolving regulatory demands.
Regulatory Support: Act as a deviation and change request owner, facilitating root cause investigations and corrective actions.
Training & Compliance: Provide training, support, and guidance on pharmacovigilance practices, ensuring adherence to regulatory guidelines.

Key Responsibilities:

Regulatory Compliance: Ensure all safety operations are in compliance with regulatory standards.
Process Leadership: Drive process improvements and share best practices within your area of expertise.
Project Management: Lead safety-related projects, ensuring timely and efficient execution.
Safety Data Review: Support audits, inspections, and regulatory submissions related to safety data.
Collaboration: Partner with affiliates and cross-functional teams to improve processes and meet regulatory requirements.

Qualifications:

Education: Graduation and/or post-graduation in Life Sciences.
Experience: Minimum 6 years of experience in pharmacovigilance, with a deep understanding of safety data management and regulatory compliance.
Skills & Knowledge:
- Extensive knowledge of pharmacovigilance principles and GxP requirements.
- Strong experience in providing training and professional support.
- In-depth knowledge of scientific regulations and global safety guidelines.
- Proven ability to drive business process improvements and work with diverse teams.
- Fluent in English, both written and spoken.

About the Department:

The Global Safety – Global Business Services (GS-GBS) team is dedicated to ensuring the safety of all medicinal products. The team handles case processing, safety report submissions, quality control of individual case safety reports (ICSR), and supports the implementation of new safety processes. The GS-GBS team also engages in medical literature surveillance and IT quality assurance activities, ensuring the safety of products worldwide.

Why Novo Nordisk?

At Novo Nordisk, we are a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Our commitment to growth and patient well-being impacts millions of lives daily. As one of the top 20 most valuable companies globally, we value the unique skills and perspectives our employees bring. If you’re looking to make an impact on a global scale, we invite you to join us.

Contact:

To apply, submit your CV online by clicking the "Apply Now" button.

Deadline:

Apply by 14th March 2025

Disclaimer:
Be cautious of fraudulent job offers. Novo Nordisk does not extend unsolicited employment offers or request payments for the recruitment process.

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