Safety Surveillance Adviser I

Novo Nordisk

2+ years

Not Disclosed

Bangalore, India

Openings: 15 Nov. 13, 2026

Job Description

Job Type: Full Time, Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Analytical Characterization, Dissolution Testing, Experimental Design, GMP/cGMP Compliance, HPLC, HPLC Analysis, Pre-formulation Studies, Regulatory Filing Support, Root Cause Analysis (RCA), Technology Transfer, UPLC

JOB DESCRIPTION: SAFETY SURVEILLANCE ADVISER I

COMPANY: Novo Nordisk Global Business Services (GBS)
DEPARTMENT: Global Patient Safety (GPS)
JOB TITLE: Safety Surveillance Adviser I
JOB CATEGORY: Regulatory Affairs & Safety – Pharmacovigilance
JOB LOCATION: Bangalore, Karnataka, India
THERAPEUTIC AREAS: Diabetes, Obesity and Rare Diseases

1. ABOUT THE ROLE

As a Safety Surveillance Adviser I at Novo Nordisk, you will play a crucial role in monitoring, evaluating and maintaining the safety profiles of pharmaceutical products throughout their entire lifecycle.

You will work within the Global Patient Safety (GPS) department, supporting product safety activities from early clinical development (First-in-Human trials) through post-marketing surveillance.

Your primary responsibility will be to establish and maintain product safety profiles, support safety labelling activities, prepare aggregate safety reports and conduct ongoing safety surveillance.

You will contribute to ensuring patient safety and maintaining a favourable benefit-risk balance for Novo Nordisk products across Diabetes, Obesity and Rare Diseases.

2. EDUCATIONAL QUALIFICATIONS

Master's degree in Medicine or MD after MBBS is preferred.
MBBS qualification with relevant pharmacovigilance experience may be considered depending on the role requirements.

3. EXPERIENCE REQUIREMENTS

Candidates should have relevant experience in the following pharmacovigilance activities:

Signal Management.
Aggregate Report Management.
Individual Case Safety Report (ICSR) Handling.
Product Safety Surveillance.
Clinical Trial Safety.
Safety Data Evaluation.
Safety Documentation and Reporting.

4. TECHNICAL KNOWLEDGE REQUIRED

Candidates should have an understanding of the following pharmacovigilance concepts and activities:

Pharmacovigilance and drug safety processes.
Signal detection, validation and assessment.
Aggregate safety reporting.
Individual Case Safety Report (ICSR) processing.
Development Safety Update Reports (DSURs).
Periodic Safety Update Reports (PSURs).
Periodic SUSAR Reports.
Risk Management Plans (RMPs).
Company Core Data Sheet (CCDS).
Safety labelling and labelling change management.
Benefit-Risk Assessment.
Clinical trial safety monitoring.
Post-marketing safety surveillance.

5. KEY ROLES AND RESPONSIBILITIES

A. SAFETY LABELLING MANAGEMENT

Act as the owner of safety sections of product labelling for the evolving Company Core Data Sheet (CCDS) for development products.
Maintain and update safety labelling for marketed products.
Review and provide safety inputs for Labelling Change Requests (LCRs).
Ensure safety-related product information is accurate and updated.
Support safety labelling activities throughout the product lifecycle.

B. AGGREGATE SAFETY REPORT PREPARATION

Prepare and support the relevant sections of the following aggregate safety reports:

Development Safety Update Reports (DSURs).
Periodic SUSAR Reports.
Periodic Safety Update Reports (PSURs).
Clinical Risk Management Plans (RMPs).

Additional responsibilities include:

Prepare safety report sections according to implementation plans.
Ensure reports meet applicable regulatory requirements.
Support report preparation as requested by Health Authorities.
Maintain accuracy and consistency of safety information.
Ensure timely completion of assigned deliverables.

C. SIGNAL MANAGEMENT AND SAFETY SURVEILLANCE

Support ongoing monitoring and evaluation of product safety profiles.
Participate in safety surveillance activities throughout the product lifecycle.
Review and evaluate relevant safety information.
Contribute to identifying and assessing potential safety signals.
Support safety analysis and benefit-risk evaluation.
Communicate important safety findings to relevant stakeholders.
Help maintain a favourable benefit-risk profile for Novo Nordisk products.

D. CROSS-FUNCTIONAL SAFETY COMMITTEE MANAGEMENT

Establish and operate cross-functional safety committees.
Chair Novo Nordisk safety committee meetings throughout the product lifecycle.
Present ongoing safety surveillance analyses and results.
Prepare safety-related information for committee discussions.
Conduct meetings at predefined intervals.
Obtain recommendations and endorsements from relevant stakeholders.
Ensure appropriate documentation and follow-up of committee decisions.

E. CLINICAL DEVELOPMENT SAFETY SUPPORT

Provide medical and safety inputs for various clinical development documents, including:

Product Development Plans.
Trial Outlines.
Clinical Trial Protocols.
Clinical Trial Reports.
Investigator's Brochures (IBs).
Integrated Safety Summaries.
Scientific Abstracts.
Planned Scientific Publications.

Additional responsibilities include:

Review clinical development documents from a safety perspective.
Provide relevant safety information during clinical development.
Ensure appropriate safety considerations are incorporated into clinical documents.
Support safety-related scientific and regulatory documentation.

F. HEALTH AUTHORITY AND ETHICS COMMITTEE COMMUNICATION

Respond to Health Authority enquiries related to product safety.
Address safety-related questions regarding clinical trial protocols.
Provide safety inputs concerning Patient Information documents.
Support safety-related aspects of Informed Consent Forms (ICFs).
Respond to Ethics Committee enquiries.
Ensure timely communication and completion of regulatory deliverables.
Coordinate deliverables to and from Data Monitoring Committees (DMCs).

G. SAFETY COMMUNICATION AND INVESTIGATOR TRAINING

Provide proactive safety communication to relevant stakeholders.
Participate in clinical project teams and trial teams.
Share important safety information with internal teams.
Support safety-related discussions during clinical development.
Conduct Investigator training when required.
Ensure investigators receive appropriate safety information.
Promote awareness of product safety requirements.

6. REQUIRED SKILLS AND COMPETENCIES

Strong understanding of pharmacovigilance and drug safety.
Knowledge of Signal Management.
Experience in Aggregate Report Management.
Understanding of ICSR handling and processing.
Knowledge of clinical trial safety requirements.
Understanding of safety surveillance activities.
Ability to evaluate and communicate complex safety information.
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills.
Ability to work in a fast-paced environment.
Flexibility to adapt to changing business and regulatory requirements.
Strong collaboration and stakeholder management skills.
Attention to detail and documentation accuracy.
Fluency in English.

7. COMPUTER AND TECHNICAL SKILLS

Candidates should be comfortable using Microsoft Office applications, including:

MS Outlook: Professional communication and email management.
MS Word: Preparation and review of safety documents and reports.
MS Excel: Safety data management, tracking and analysis.
MS PowerPoint: Preparation of safety presentations and committee meeting materials.

8. KEY STAKEHOLDERS AND DEPARTMENTS

The Safety Surveillance Adviser I will collaborate with several internal and external stakeholders.

A. INTERNAL STAKEHOLDERS

GLOBAL PATIENT SAFETY (GPS): Monitoring and evaluating product safety profiles.
RESEARCH & DEVELOPMENT (R&D): Providing safety inputs during clinical development.
CLINICAL DEVELOPMENT TEAMS: Supporting clinical trial safety activities.
REGULATORY AFFAIRS: Coordinating safety-related regulatory requirements and submissions.
MEDICAL TEAMS: Providing scientific and medical safety inputs.
CROSS-FUNCTIONAL SAFETY COMMITTEES: Presenting safety surveillance results and supporting benefit-risk discussions.
GLOBAL SAFETY HUB – SØBORG, DENMARK: Collaborating on global pharmacovigilance and safety surveillance activities.

B. EXTERNAL STAKEHOLDERS

Health Authorities.
Ethics Committees.
Clinical Investigators.
Data Monitoring Committees (DMCs).
Other relevant clinical and regulatory stakeholders.

9. DEPARTMENT OVERVIEW – GLOBAL PATIENT SAFETY (GPS)

The Safety Surveillance Adviser team operates within the Global Patient Safety (GPS) department at Novo Nordisk Global Business Services (GBS), Bangalore.

The team is responsible for monitoring, evaluating and communicating the safety profiles of Novo Nordisk products throughout their lifecycle.

The major therapeutic areas covered include:

Diabetes.
Obesity.
Rare Diseases.

The Bangalore team collaborates closely with global teams in Søborg, Denmark, and other international partner teams.

The department operates in a dynamic, collaborative and fast-paced environment, with a primary focus on patient safety and maintaining a favourable benefit-risk balance.

10. RESEARCH & DEVELOPMENT (R&D) DEPARTMENT OVERVIEW

The Research & Development department focuses on transforming scientific ideas into innovative therapies through clinical research and development.

Key focus areas include:

Early-stage drug development.
Clinical research and testing.
Clinical trial safety.
Scientific innovation.
Data-driven research.
Development of innovative therapies.
Collaboration across global research teams.

The department uses scientific research, AI tools and human data to support the development of future treatments.

11. CAREER DEVELOPMENT AND WORK CULTURE

Novo Nordisk offers opportunities for professional growth and development through:

Exposure to global pharmacovigilance operations.
Opportunities to work with international safety teams.
Practical experience in product safety surveillance.
Exposure to clinical development safety activities.
Opportunities to develop expertise in aggregate reporting and signal management.
Cross-functional collaboration with medical, clinical and regulatory teams.
Continuous learning and professional development.
Opportunities to work on safety activities covering the entire product lifecycle.

12. IMPORTANT JOB DETAILS

PARTICULARS	DETAILS
Company	Novo Nordisk Global Business Services (GBS)
Job Title	Safety Surveillance Adviser I
Department	Global Patient Safety (GPS)
Category	Regulatory Affairs & Safety – Pharmacovigilance
Location	Bangalore, Karnataka, India
Preferred Qualification	MD / Master's in Medicine
Experience	Relevant experience in Signal Management, Aggregate Management and ICSR Handling
Therapeutic Areas	Diabetes, Obesity and Rare Diseases
Work Function	Product Safety Surveillance

13. OVERALL JOB OBJECTIVE

The primary objective of the Safety Surveillance Adviser I is to monitor, evaluate, maintain and communicate the safety profiles of Novo Nordisk products throughout their lifecycle, from early clinical development to post-marketing surveillance.

The role involves safety labelling management, aggregate safety reporting, signal management, clinical trial safety support, benefit-risk assessment and communication with Health Authorities and other stakeholders.

The selected candidate will contribute to maintaining patient safety, ensuring regulatory compliance and supporting a favourable benefit-risk balance for Novo Nordisk medicines.

14. KEY FOCUS AREAS OF THIS ROLE

Global Pharmacovigilance.
Product Safety Surveillance.
Signal Management.
Aggregate Safety Reporting.
ICSR Handling.
DSUR Preparation.
PSUR Preparation.
Periodic SUSAR Reporting.
Risk Management Plans (RMPs).
Company Core Data Sheet (CCDS).
Safety Labelling Management.
Labelling Change Requests (LCRs).
Clinical Trial Safety.
Benefit-Risk Assessment.
Health Authority Communication.
Ethics Committee Communication.
Investigator Training.
Cross-functional Safety Committee Management.

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Safety Surveillance Adviser I

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