Sr. Safety Medical Writer
Company: Novo Nordisk Global Business Services (GBS)
Department: Safety Medical Writing, Safety Surveillance, Global Patient Safety
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
About the Role
Novo Nordisk is seeking an experienced Senior Safety Medical Writer to join its Global Patient Safety team. This role is responsible for independently managing high-complexity pharmacovigilance and safety writing deliverables while ensuring regulatory compliance, scientific accuracy, and timely submissions.
The ideal candidate will possess extensive expertise in aggregate safety reporting, risk management documentation, pharmacovigilance regulations, and scientific communication. This position offers the opportunity to contribute directly to global patient safety initiatives while collaborating with multidisciplinary teams across the organization.
Key Responsibilities
Aggregate Safety Reporting
Prepare complex aggregate safety reports in compliance with global regulatory requirements.
Author and review:
Periodic Safety Update Reports (PSURs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Benefit-Risk Evaluation Documents
Ensure scientific accuracy, consistency, and compliance in all safety deliverables.
Regulatory Documentation & Health Authority Support
Prepare responses to Health Authority queries and requests.
Support regulatory submissions related to pharmacovigilance activities.
Contribute to safety sections of regulatory dossiers and submissions.
Ensure alignment with global and local regulatory requirements.
Scientific Writing & Data Interpretation
Analyze and interpret safety surveillance data.
Translate complex scientific information into clear and concise regulatory documents.
Present safety findings effectively for internal and external stakeholders.
Ensure high-quality scientific communication and data presentation.
Cross-Functional Collaboration
Collaborate with:
Safety Physicians
Pharmacovigilance Scientists
Regulatory Affairs Teams
Clinical Development Teams
Epidemiology and Biostatistics Teams
Provide strategic input on document structure, content, and safety messaging.
Support global safety review and governance processes.
Process Improvement & Innovation
Contribute to innovation initiatives within Safety Medical Writing.
Support implementation of AI-driven and structured authoring solutions.
Identify opportunities for process optimization and automation.
Improve efficiency, scalability, and quality of medical writing deliverables.
Guideline & Compliance Management
Monitor updates to global pharmacovigilance regulations and guidance documents.
Evaluate the impact of regulatory changes on safety documentation.
Ensure compliance with:
ICH Guidelines
GVP Guidelines
FDA Requirements
EMA Regulations
Internal SOPs and Quality Standards
Leadership & Mentorship
Serve as a subject matter expert within Safety Medical Writing.
Mentor and guide junior medical writers.
Support competency development and knowledge-sharing initiatives.
Provide technical expertise on complex safety writing projects.
Project Management
Manage multiple high-priority projects simultaneously.
Ensure timely delivery of high-quality documents.
Coordinate with stakeholders to meet regulatory submission timelines.
Support strategic planning and workload prioritization.
About the Department
Safety Medical Writing is a global function within Global Patient Safety, operating from Bangalore, India and Søborg, Denmark.
The department is responsible for preparing high-quality pharmacovigilance and safety surveillance documents that communicate the evolving safety profile of Novo Nordisk products. The team supports both marketed and investigational products worldwide, ensuring patient safety remains the highest priority.
Global Patient Safety comprises more than 400 highly qualified professionals working across pharmacovigilance, risk management, epidemiology, and safety surveillance functions.
Required Qualifications
Education
M.Pharm
Pharm.D
MBBS
MD
M.Sc (Life Sciences)
Ph.D. in Life Sciences
Veterinary Sciences
Biological Sciences
Preferred
Advanced scientific or healthcare qualification.
Specialized training in Pharmacovigilance or Medical Writing.
Experience
Minimum 7+ years of experience in:
Pharmacovigilance
Drug Safety
Safety Medical Writing
Aggregate Safety Reporting
Regulatory Medical Writing
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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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
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Saarbrucken |Switzerland :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
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Santiago |Bosnia and Herzegovina :
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