Pharmacovigilance Job at Novo Nordisk, Bangalore | MD Professionals Are Welcome!
Novo Nordisk is a global healthcare company specializing in diabetes, obesity, and rare diseases. With a commitment to patient safety and innovative solutions, Novo Nordisk operates in Bangalore, India, as part of its Global Business Services (GBS). The organization is dedicated to shaping the safety profile of medicines that reach patients worldwide.
About the role
The Safety Surveillance Adviser I role at Novo Nordisk involves central responsibilities in product safety, including establishing safety profiles during development, maintaining labeling for marketed products, and conducting ongoing surveillance of Novo Nordisk products across their lifecycle. This position is crucial in ensuring that safety standards are upheld throughout the product journey.
Responsibilities
- Act as Owner of the safety sections of labeling for the evolving Company Core Data Sheet (CCDS) for development products.
- Prepare relevant sections of Development Safety Update Reports (DSURs), periodic SUSAR reports, and Periodic Safety Update Reports (PSURs).
- Establish and chair the Novo Nordisk cross-functional safety committee throughout the product lifecycle.
- Provide safety input to Product Development Plans, Trial Outlines, Protocols, and Clinical Trial Reports.
- Respond to enquiries from Health Authorities regarding safety aspects of protocols and ensure deliverables to Data Monitoring Committees.
- Deliver proactive safety communication through participation in project and trial teams.
Requirements
- A Master’s degree in Medicine/MD post MBBS (preferred).
- Relevant experience in Signal Management, Aggregate Management, and Individual Case Safety Report (ICSR) handling.
- Ability to quickly adjust to changes in a continuously developing environment.
- Strong communication skills and fluency in English.
Skills
- Comfortable use of the Microsoft Office package (Outlook, Word, Excel, and PowerPoint).
- Strong analytical skills to interpret complex safety data.
- Ability to convey complex safety information clearly to diverse stakeholders.
- Passion for patient safety and commitment to quality.
Location: Bangalore, Karnataka, India