Associate Safety Operations Adviser

Novo Nordisk; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Novo Nordisk is seeking a Safety Operations Adviser to join the Global Safety team in Bengaluru. You will oversee adverse event collection, evaluation, and reporting across trials and post-marketing to ensure regulatory compliance.

The role requires a medical postgraduate degree and 0–1 year of pharmacovigilance experience, with strong English, analytical and collaborative skills. Global safety collaboration and continuous learning are emphasized.

Qualifications

• Postgraduate degree in Medicine (MD/MBBS), preferably with pharmacovigilance experience.
• 0–1 year of experience in Pharmacovigilance or a related field within the pharmaceutical industry is preferred.
• Fluent in English, with strong analytical, organizational and planning skills.

Responsibilities

• Collect, evaluate, and report adverse events (AEs) and serious adverse events (SAEs) from clinical trials, clinical use, and post-marketing.
• Review AE, pregnancy, and safety forms for consistency and accuracy in coding using MedDRA; participate in coding group meetings.
• Ensure compliance with global regulatory requirements for safety data collection, evaluation and reporting; support safety team meetings and protocol reviews.
• Contribute to the reconciliation process of SAEs with clinical trial databases and ensure GMP/GCP compliance.

Skills

Clinical pharmacology

Computer systems

English proficiency

Analytical skills

Independent work

Communication skills

Pharmacovigilance knowledge

Education

MD/MBBS

Tools

MedDRA

Job description

About Novo Nordisk

Novo Nordisk is a leading global healthcare company with a legacy of over 100 years in driving change to combat serious chronic diseases. Our work, particularly in diabetes care, has transformed lives for millions of people worldwide. Our success has made us one of the 20 most valuable companies globally by market cap.

Department Overview: Global Safety

The Global Safety department in Bangalore is responsible for ensuring the safety and quality of Novo Nordisks clinical development and marketed products. This includes managing the global reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials, investigator-sponsored trials, named patient supplies, and third-party trials. The department works to maintain patient safety and regulatory compliance throughout the lifecycle of Novo Nordisks products.

The Role: Safety Operations Adviser

Location: Global

Department: Global Safety

As a Safety Operations Adviser in the GS-GBS SO Safety Operations department, you will be responsible for ensuring compliance with global regulatory requirements for the collection, evaluation, and reporting of safety data. Your work will support the safe use of Novo Nordisks products by evaluating adverse events, ensuring consistent coding, and collaborating across teams to ensure accurate safety assessments.

Key Responsibilities

Adverse Event Management:

• Collect, evaluate, and report adverse events (AEs) and serious adverse events (SAEs) from clinical trials, clinical use, and post-marketing.
• Perform medical evaluation of AEs and SAEs, including evaluating possible causal relationships.
• Ensure timely and accurate reporting to relevant health authorities to avoid regulatory delays.
• Prepare follow-up questions and consistency checks for clinical and post-marketing cases.

Safety Data Handling:

• Review AE, pregnancy, and safety forms for consistency and accuracy in coding using MedDRA.
• Participate in coding group and case handling meetings.
• Ensure up-to-date knowledge on safety regulations through continuous learning and participation in relevant courses and meetings.

Project Support & Collaboration:

• Collaborate with clinical project teams and safety meetings as needed to ensure safety requirements are met.
• Review clinical protocols to ensure safety data is captured accurately.
• Provide support to Data Management colleagues on product-related safety queries.

Compliance & Regulatory Oversight:

• Ensure compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) in all safety-related tasks.
• Contribute to the reconciliation process of SAEs with clinical trial databases.

Qualifications

Education:

• Postgraduate degree in Medicine (MD/MBBS), preferably with relevant experience in Pharmacovigilance.
• 0-1 year of experience in Pharmacovigilance or a related field within the pharmaceutical industry is preferred.

Skills & Knowledge:

• Good understanding of clinical pharmacology and the clinical manifestations of diseases.
• Proficient with computer systems and databases.
• Fluent in English (written and spoken).
• Strong analytical, organizational, and planning skills.
• Ability to work independently and manage projects efficiently.
• Flexibility and strong communication skills to collaborate with various departments.
• Knowledge of Pharmacovigilance, clinical development, and regulatory requirements is essential.

Working at Novo Nordisk

At Novo Nordisk, we are more than just a company; we are a community united by a shared purposeto make life better for people with chronic diseases. We embrace the unique skills and perspectives of our employees, creating an inclusive culture that drives innovation and impact. Together, we strive to be the best company for the world, not just the best in the world. .

Application Deadline: 30th November 2024

Equal Opportunity Commitment

At Novo Nordisk, we are committed to an inclusive recruitment process and equal opportunities for all applicants. We celebrate the diversity of our employees and the communities we serve, ensuring that everyones contributions are valued and heard. Together, were life-changing. .