Corporate Pharmacovigilance Job at Novo Nordisk, Bengaluru | Work with the Global Patient Safety Team!
About the role
Novo Nordisk is hiring a Safety Surveillance Adviser for its Global Patient Safety team in Bengaluru. This role offers the chance to work on global safety surveillance, risk management, regulatory reporting, and clinical development while collaborating with international teams.
Responsibilities
- Establish and maintain the safety profile of Novo Nordisk products during development and post-marketing phases.
- Perform continuous safety surveillance using global safety data from worldwide sources.
- Monitor and communicate drug safety issues internally and to Health Authorities.
- Chair and manage cross-functional product safety committees throughout the product lifecycle.
- Maintain and update the Company Core Data Sheet (CCDS) and marketed product labeling.
- Review Labeling Change Requests (LCRs) and provide safety-related recommendations.
- Prepare Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), SUSAR reports, and Risk Management Plans (RMPs).
- Respond to safety-related queries from Health Authorities and Novo Nordisk affiliates.
- Provide safety input for Product Development Plans, clinical trial protocols, Clinical Study Reports, Investigator’s Brochures, integrated safety summaries, abstracts, and scientific publications.
- Participate in project teams and clinical trial groups to provide proactive safety guidance.
- Conduct investigator safety training when required.
- Support Data Monitoring Committees (DMCs), Ethics Committees (ECs), and Health Authorities with safety-related documentation and responses.
- Ensure patient safety throughout the clinical development lifecycle.
Requirements
- Master’s in Medicine or MD (Post MBBS) is preferred.
- Relevant experience in Signal Management, Aggregate Safety Reporting, and Individual Case Safety Reports (ICSR).
- Prior experience in Pharmacovigilance or Drug Safety is preferred.
Qualifications
Strong knowledge of Pharmacovigilance and Drug Safety.
Experience in Signal Management.
Knowledge of Aggregate Safety Reporting (DSUR, PSUR, SUSAR, RMP).
Experience with Individual Case Safety Reports (ICSR).
Understanding of clinical trial safety monitoring.
Familiarity with regulatory guidelines and Health Authority requirements.
Excellent analytical and problem-solving skills.
Strong written and verbal communication skills.
Ability to collaborate with global cross-functional teams.
Strong organizational and stakeholder management skills.
Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
Ability to adapt quickly in a dynamic and fast-paced work environment.
Skills
- Strong knowledge of Pharmacovigilance and Drug Safety.
- Experience in Signal Management.
- Knowledge of Aggregate Safety Reporting (DSUR, PSUR, SUSAR, RMP).
- Experience with Individual Case Safety Reports (ICSR).
- Understanding of clinical trial safety monitoring.
- Familiarity with regulatory guidelines and Health Authority requirements.
- Excellent analytical and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to collaborate with global cross-functional teams.
- Strong organizational and stakeholder management skills.
- Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
- Ability to adapt quickly in a dynamic and fast-paced work environment.
Benefits
- Join a globally recognized leader in diabetes, obesity, and rare disease research.
- Work with the Global Patient Safety team on international pharmacovigilance projects.
- Gain exposure to global regulatory authorities and drug safety reporting.
- Collaborate with multidisciplinary teams across India and Denmark.
- Contribute to patient safety throughout the lifecycle of innovative medicines.
- Develop expertise in signal detection, safety surveillance, and risk management.
- Work in a collaborative, inclusive, and innovation-driven environment.
- Access continuous learning and professional development opportunities.
- Build a rewarding career with one of the world’s most respected pharmaceutical companies.
- Be part of an organization committed to improving global healthcare and patient outcomes.
Pay
TBD
Schedule
TBD
Benefits
- TBD