Safety Surveillance Adviser I – Global Patient Safety (GPS)
Company: Novo Nordisk Global Business Services (GBS)
Location: Bangalore, Karnataka, India
Department: Regulatory Affairs & Safety – Pharmacovigilance
Employment Type: Full-Time
Experience Required: 3–6 Years (Estimated based on responsibilities and required pharmacovigilance expertise)
Salary Package
Expected CTC: ₹12 LPA – ₹25 LPA (Estimated market range based on medical qualification, pharmacovigilance experience, signal management expertise, and organization. Actual compensation may vary.)
Job Summary
The Safety Surveillance Adviser I is responsible for supporting Global Patient Safety (GPS) activities across the product lifecycle, from clinical development through post-marketing surveillance. The role focuses on safety signal management, aggregate safety reporting, risk management activities, regulatory safety documentation, and maintaining a favourable benefit-risk profile for Novo Nordisk products.
The position requires close collaboration with global safety teams, regulatory functions, clinical development teams, and external stakeholders to ensure effective safety monitoring and regulatory compliance.
Key Responsibilities
Safety Surveillance & Signal Management
Support ongoing safety surveillance activities for products across development and marketed stages.
Perform safety data review, evaluation, and interpretation to support benefit-risk assessments.
Contribute to signal management activities, including identification, evaluation, and documentation of potential safety signals.
Support Individual Case Safety Report (ICSR) review and safety data analysis.
Present safety findings and recommendations through cross-functional safety committees.
Aggregate Safety Reporting
Prepare safety sections for regulatory documents, including:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)
Periodic SUSAR reports
Clinical Risk Management Plans (RMPs)
Provide medical and safety input into aggregate reports according to regulatory requirements and internal procedures.
Support Health Authority submissions and responses related to product safety.
Safety Labelling & Regulatory Support
Support ownership and maintenance of safety sections within the Company Core Data Sheet (CCDS).
Review and provide safety input for labelling change requests (LCRs).
Contribute safety information for:
Clinical trial protocols
Investigator Brochures
Clinical Trial Reports
Integrated Safety Summaries
Publications and scientific abstracts
Respond to safety-related queries from Health Authorities and Ethics Committees.
Cross-Functional Collaboration
Participate in project teams and clinical trial teams to provide proactive safety input.
Collaborate with Medical Affairs, Regulatory Affairs, Clinical Development, and Data Monitoring Committees.
Support safety communication and investigator training activities when required.
Maintain effective relationships with global GPS teams and external stakeholders.
Required Qualifications
Master's degree in Medicine / MD after MBBS preferred.
Bachelor's or advanced degree in Medicine, Pharmacy, Life Sciences, or related healthcare discipline may be considered based on experience.
Experience in Pharmacovigilance, Clinical Safety, or Drug Safety.
Hands-on experience in:
Signal Management
Aggregate Safety Reporting
Individual Case Safety Reports (ICSRs)
Risk Management activities
Required Skills
Strong understanding of global pharmacovigilance regulations and safety surveillance processes.
Experience with signal detection, evaluation, and management.
Knowledge of DSUR, PSUR/PBRER, SUSAR reporting, and RMP processes.
Ability to interpret clinical safety data and communicate medical insights.
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills.
Ability to communicate complex safety information clearly to different stakeholders.
Strong proficiency in Microsoft Office applications:
Word
Excel
PowerPoint
Outlook
Ability to adapt quickly in a dynamic and evolving environment.
Preferred Skills
Experience working with global pharmaceutical companies or CROs.
Knowledge of ICH guidelines and GVP modules.
Experience supporting Health Authority interactions.
Experience in safety governance committees and cross-functional safety reviews.
Therapeutic area experience in Diabetes, Obesity, Rare Diseases, or Chronic Disease Management.
Experience with pharmacovigilance databases and safety analytics tools.
Career Opportunity at Novo Nordisk
Opportunity to work within Global Patient Safety (GPS) on innovative therapies.
Exposure to global pharmacovigilance operations and product lifecycle management.
Collaboration with international safety teams across Denmark and other global hubs.
Professional growth opportunities through continuous learning and development.
Opportunity to contribute directly to patient safety and healthcare innovation.
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