Safety Surveillance Adviser – Novo Nordisk
Location
Bangalore, Karnataka, India
Novo Nordisk Global Business Services (GBS)
Job Type
Full-time
Department
Global Patient Safety (GPS)
Regulatory Affairs & Safety Pharmacovigilance
Experience Required
Relevant experience in:
Pharmacovigilance (PV)
Signal Management
Aggregate Safety Reporting
Individual Case Safety Reports (ICSR)
Drug Safety Surveillance
Experience in clinical safety and lifecycle safety management preferred.
Estimated Salary Package (Market Standard)
₹18 – ₹35 LPA (approx.), depending on pharmacovigilance experience, medical background, safety surveillance expertise, and interview performance.
Job Overview
The Safety Surveillance Adviser is responsible for establishing and maintaining the safety profile of Novo Nordisk products throughout their lifecycle, including clinical development and post-marketing phases. The role focuses on global safety surveillance, signal detection, benefit-risk assessment, regulatory safety documentation, and communication of safety findings to internal stakeholders and Health Authorities.
The position requires close collaboration with Global Patient Safety teams, clinical development groups, regulatory functions, and cross-functional safety committees to ensure patient safety and regulatory compliance.
Key Responsibilities
Safety Surveillance & Signal Management
Conduct ongoing and systematic surveillance of product safety information from global sources.
Evaluate safety data during:
Clinical development phases
Pre-approval activities
Post-marketing lifecycle management
Support signal detection, evaluation, and management activities.
Present safety analyses and recommendations to cross-functional safety committees.
Maintain a favorable benefit-risk balance for assigned products.
Aggregate Safety Reporting
Prepare and contribute to global safety documents, including:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Serious Unexpected Suspected Adverse Reaction (SUSAR) reports
Risk Management Plans (RMPs)
Ensure reports meet regulatory requirements and internal quality standards.
Product Labeling Activities
Own safety sections of the Company Core Data Sheet (CCDS).
Maintain safety-related labeling information for marketed products.
Review Label Change Requests (LCRs) and provide safety input.
Support regulatory submissions related to safety updates.
Clinical Trial Safety Support
Provide safety input into:
Clinical trial protocols
Investigator’s Brochures (IB)
Clinical Trial Reports (CTR)
Integrated Safety Summaries
Publications and scientific abstracts
Support safety-related clinical development activities.
Review patient information and informed consent documents from a safety perspective.
Cross-Functional Collaboration
Participate in project teams and clinical trial working groups.
Establish and support product safety committees.
Present safety analyses and recommendations to stakeholders.
Coordinate with:
Health Authorities (HAs)
Ethics Committees (ECs)
Data Monitoring Committees (DMCs)
Global Patient Safety teams
Regulatory Communication
Respond to safety-related queries from:
Health Authorities
Internal affiliates
Regulatory stakeholders
Support proactive safety communication activities.
Ensure compliance with global pharmacovigilance regulations.
Educational Qualification
Preferred:
Master’s degree in Medicine / MD after MBBS.
Other relevant qualifications:
Pharmacy
Life Sciences
Clinical Research
Medical Sciences
Related healthcare disciplines
Required Skills
Strong understanding of Pharmacovigilance principles.
Experience with:
Signal Management
Aggregate Reporting
ICSR Management
Safety Surveillance
Knowledge of clinical trial safety processes.
Understanding of regulatory requirements for drug safety.
Ability to analyze and interpret safety data.
Strong written and verbal communication skills.
Proficiency with Microsoft Office:
Word
Excel
PowerPoint
Outlook
Ability to adapt quickly in a changing global environment.
Preferred Experience
Experience working in:
Global Pharmacovigilance teams
Pharmaceutical companies
CRO environments
Clinical development safety functions
Experience preparing regulatory safety documents.
Experience participating in safety review committees.
Medical background with drug safety expertise.
Work Environment
Based in Novo Nordisk Global Business Services, Bangalore.
Collaboration with global teams in Denmark and other international locations.
Exposure to global drug development, regulatory safety operations, and lifecycle management.
Who Should Apply
Pharmacovigilance professionals, Safety Surveillance Specialists, Drug Safety Scientists, Medical Safety Associates, and Clinical Safety experts with experience in signal detection, aggregate reporting, ICSR management, and global safety surveillance.
Medical professionals (MD/MBBS) with interest or experience in Global Patient Safety and Regulatory Affairs.
Uttar Pradesh :
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