Pharmacovigilance Job at Novo Nordisk
Are you passionate about ensuring the safety of pharmaceutical products? Novo Nordisk is seeking a dedicated Safety Surveillance Adviser I to join their team in Bangalore, India. This Pharmacovigilance Job in Bangalore is integral to maintaining high safety standards for Novo Nordisk’s diverse range of products. As part of the Global Business Services, the position offers an opportunity to contribute significantly to patient safety worldwide.
About Novo Nordisk:
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, making it a pivotal player in the pharmacovigilance space.
Job Details:
- Role: Safety Surveillance Adviser I
- Location: Bangalore, Karnataka, IN
- Category: Reg Affairs & Safety Pharmacovigilance
Job Description:
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.
Key Responsibilities:
- Acting as Owner of the safety sections of labeling for the evolving Company Core Data Sheet (CCDS) for development products.
- Preparing relevant sections of Development Safety Update Reports (DSURs), periodic SUSAR reports, and Periodic Safety Update Reports (PSURs).
- Establishing and chairing the Novo Nordisk cross-functional safety committee throughout the product lifecycle in this Pharmacovigilance Job in Bangalore.
- Providing safety input to Product Development Plans, Trial Outlines, Protocols, and Clinical Trial Reports.
- Responding to enquiries from Health Authorities regarding safety aspects of protocols and ensuring deliverables to Data Monitoring Committees.
- Delivering proactive safety communication through participation in project and trial teams.
Eligibility Criteria for the Pharmacovigilance Job:
- 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.
Required Skills for the Pharmacovigilance Job:
- 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.
