Safety Surveillance Adviser
Company: Novo Nordisk Global Business Services (GBS)
Department: Global Patient Safety (GPS)
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
About the Role
Novo Nordisk is seeking an experienced Safety Surveillance Adviser to join its Global Patient Safety team. This role is responsible for monitoring, evaluating, and communicating the safety profile of Novo Nordisk products throughout their lifecycle, from clinical development to post-marketing surveillance.
The position plays a critical role in ensuring patient safety through signal detection, aggregate safety reporting, risk management, labeling maintenance, and regulatory safety compliance. The Safety Surveillance Adviser will collaborate with global cross-functional teams and health authorities to maintain a favorable benefit-risk profile for Novo Nordisk products.
Key Responsibilities
Product Safety Surveillance
Perform ongoing and systematic surveillance of product safety during pre-approval and post-approval phases.
Monitor safety information from worldwide sources.
Evaluate emerging safety signals and potential risks.
Ensure continuous assessment of product benefit-risk balance.
Signal Management & Safety Evaluation
Identify, assess, validate, and monitor safety signals.
Perform signal detection and signal evaluation activities.
Conduct benefit-risk assessments based on available safety data.
Support safety issue escalation and risk mitigation strategies.
Labeling Management
Own safety sections of the Company Core Data Sheet (CCDS) for development products.
Maintain product labeling for marketed products.
Review Labeling Change Requests (LCRs) and provide safety recommendations.
Ensure safety information is accurately reflected in product labeling.
Aggregate Safety Reporting
Author and review:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs/PBRERs)
Serious Unexpected Suspected Adverse Reaction (SUSAR) Reports
Risk Management Plans (RMPs)
Ensure compliance with global pharmacovigilance regulations and reporting requirements.
Clinical Development Safety Support
Provide safety input to:
Product Development Plans (PDPs)
Clinical Trial Protocols
Trial Outlines
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Integrated Safety Summaries
Scientific Publications and Abstracts
Support safety strategy throughout clinical development.
Health Authority & Regulatory Interactions
Respond to safety-related questions from Health Authorities.
Support responses to Ethics Committees (ECs).
Participate in regulatory inspections and audits.
Ensure timely submission of required safety documentation.
Cross-Functional Safety Leadership
Establish, chair, and manage cross-functional Safety Committees.
Present safety analyses and recommendations to stakeholders.
Facilitate safety review meetings and decision-making processes.
Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs teams.
Data Monitoring Committee (DMC) Support
Coordinate safety deliverables for Data Monitoring Committees.
Ensure timely communication of safety findings.
Support DMC meetings and documentation requirements.
Safety Communication & Training
Provide proactive safety communication to project and trial teams.
Conduct investigator safety training when required.
Communicate emerging risks and mitigation strategies effectively.
About the Department
The Safety Surveillance Adviser Team is part of Novo Nordisk's Global Patient Safety organization and is based in Bangalore, India.
The team supports the safety monitoring of products across therapeutic areas including:
Diabetes
Obesity
Rare Diseases
Working closely with global teams in Denmark and other international locations, the department ensures regulatory compliance, patient safety, and maintenance of a favorable benefit-risk profile for Novo Nordisk products worldwide.
Required Qualifications
Education
Preferred
MD (Doctor of Medicine)
MBBS with Postgraduate Medical Qualification
Also Considered
M.Pharm
Pharm.D
M.Sc (Life Sciences)
Pharmacology
Biotechnology
Other Relevant Healthcare or Life Science Degrees
Experience
Experience in Pharmacovigilance and Drug Safety.
Prior exposure to:
Signal Management
Aggregate Reporting
Safety Surveillance
ICSR Management
Risk Management Activities
Experience within pharmaceutical, biotechnology, or CRO environments preferred.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Netherlands |Remote Australia :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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