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Safety Surveillance Adviser

Novo Nordisk
Novo Nordisk
2-5 years
preferred by company
Bangalore, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Job Title: Safety Surveillance Adviser

Company: Novo Nordisk
Location: Bangalore, India
Department: Global Patient Safety (GPS)
Employment Type: Full-Time
Industry: Pharmacovigilance / Drug Safety / Global Patient Safety / Regulatory Affairs

Job Overview

Novo Nordisk is hiring a Safety Surveillance Adviser to lead product safety surveillance, aggregate safety reporting, signal management, benefit-risk evaluation, labeling maintenance, and regulatory safety communication across product lifecycle stages.

This role is ideal for professionals with expertise in pharmacovigilance, signal detection, aggregate reporting, ICSR review, safety risk management, clinical safety, and health authority communication.

The position supports both pre-approval and post-marketing safety surveillance for global product portfolios.


Key Responsibilities

Product Safety Surveillance

Lead ongoing safety monitoring for products throughout their lifecycle.

Responsibilities include:

  • Pre-approval safety surveillance
  • Post-marketing safety surveillance
  • Benefit-risk evaluation
  • Safety trend monitoring
  • Global safety intelligence review

Monitor safety information from:

  • Clinical trials
  • Spontaneous reports
  • Literature
  • Regulatory sources
  • Worldwide safety databases

Ensure timely identification of emerging safety risks.


Signal Management

Lead pharmacovigilance signal activities including:

  • Signal detection
  • Signal validation
  • Signal assessment
  • Signal prioritization
  • Safety issue escalation

Responsibilities:

  • Analyze safety trends
  • Identify potential safety concerns
  • Support signal communication
  • Recommend risk mitigation actions

Strong signal management expertise required.


Aggregate Safety Reporting

Author and support major aggregate safety deliverables.

Includes:

  • DSURs (Development Safety Update Reports)
  • PSURs / PBRERs
  • SUSAR aggregate reports
  • Clinical Risk Management Plans (RMPs)
  • Integrated safety summaries

Responsibilities:

  • Safety data interpretation
  • Medical safety writing
  • Regulatory submission support
  • Cross-functional review coordination

Labeling Safety Management

Act as owner/reviewer of product safety labeling content.

Responsibilities:

  • Company Core Data Sheet (CCDS) safety sections
  • Marketed product label maintenance
  • Labeling Change Request (LCR) review
  • Safety content updates
  • Risk communication support

Ensure labels reflect current benefit-risk understanding.


Clinical Trial Safety Oversight

Provide safety leadership across clinical development.

Support:

  • Protocol safety review
  • Trial safety strategy
  • Clinical safety risk assessment
  • Safety oversight for studies
  • Development safety planning

Provide input into:

  • Product Development Plans (PDP)
  • Trial outlines
  • Clinical protocols
  • Clinical Study Reports (CSRs)
  • Investigator Brochures (IBs)

Health Authority & Ethics Committee Communication

Respond to regulatory safety requests from:

  • Health Authorities (HAs)
  • Ethics Committees (ECs)
  • Internal affiliates

Responsibilities:

  • Safety clarifications
  • Regulatory responses
  • Safety justification documentation
  • Query resolution

Strong regulatory communication capability required.


Safety Committee Leadership

Establish and lead cross-functional safety governance forums.

Responsibilities:

  • Chair safety committee meetings
  • Present safety analyses
  • Drive safety recommendations
  • Support benefit-risk decisions
  • Ensure governance documentation

Lead structured decision-making for product safety oversight.


Data Monitoring Committee (DMC) Support

Coordinate safety deliverables for:

  • Data Monitoring Committees
  • Safety governance boards
  • Clinical oversight committees

Ensure timely exchange of critical safety information.


Investigator Training & Safety Communication

Provide proactive medical safety communication.

Responsibilities:

  • Investigator safety training
  • Safety presentations
  • Clinical team safety guidance
  • Safety issue awareness

Support internal and external stakeholder understanding.


Scientific Communication Support

Provide safety input for:

  • Publications
  • Abstracts
  • Scientific communications
  • Medical documents
  • Internal safety reviews

Ensure medically accurate and compliant safety interpretation.


Required Qualifications

Education

Preferred:

  • MD / Doctor of Medicine
  • Post-MBBS postgraduate qualification

Strong medical background preferred.


Required Experience

Hands-on expertise in:

  • Signal Management
  • Aggregate Reporting
  • ICSR review / pharmacovigilance operations
  • Clinical safety