Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding 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.

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.

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 workplace.

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.

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