PHARMAFull-time
Sr Safety Medical Writer
BANGALORE (IN)ONSITEPOSTED: 9/21/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVO NORDISKPharmaceuticals / Healthcare
ROLE OVERVIEW
Senior pharmacovigilance medical writing role focused on complex aggregate safety reports, regulatory documentation, scientific communication, and continuous improvement within Global Patient Safety.
ROLE DEFINITION & RESPONSIBILITIES
- •Prepare complex aggregate safety reports, Risk Management Plans and Health Authority responses
- •collaborate with cross-functional teams on scientific writing and timely safety reporting
- •evaluate and implement changes in local and global pharmacovigilance guidelines
- •contribute to technical optimisation and innovation projects
- •drive process improvement and medical writing competency development
- •support skill building across the Safety Medical Writing function
- •mentor and advise junior team members on complex documents and writing practices
Reporting Hierarchy: Part of Safety Medical Writing within Global Patient Safety; collaborates with global cross-functional teams and may provide expert guidance to junior medical writers; exact individual reporting line not stated
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master's degree and/or PhD in Life Sciences such as Pharmacy, Medicine, Veterinary or Biological Sciences
- more than 7 years of pharmacovigilance and medical writing experience
- expert knowledge of PSURs, DSURs and RMPs
- strong understanding of applicable guidelines and regulations
- excellent analytical and communication skills
- fluent written and spoken English
- ability to manage multiple projects and deliver high-quality documents on schedule
PREFERRED QUALIFICATIONS
- •Experience with artificial intelligence, structured authoring or technical solutions in medical writing
- •experience with complex Marketing Authorisation Application submissions
- •strong scientific data presentation
- •experience leading cross-functional stakeholders and negotiating solutions
REQUIRED VERIFIED SKILLS
Pharmacovigilance
Medical Writing
Aggregate Safety Reports
PSUR
DSUR
RMP
Health Authority Responses
Regulatory Compliance
Scientific Writing
Safety Data Analysis
Guideline Assessment
Project Management
Stakeholder Management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Global healthcare company benefits, learning and development opportunities, and career-focused benefits designed around career and life stages.
No salary information disclosed in the job posting.
ORGANIZATION CONTEXT & CULTURE
Novo Nordisk is a global healthcare company focused on developing solutions for serious chronic diseases. Its Global Patient Safety organisation has more than 400 professionals and monitors the safety profile of products marketed and under development worldwide.
TEAM SIZE: 70,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare
Culture: Determination, curiosity, continuous improvement, diverse thinking, shared purpose, mutual respect, collaboration, transparency and ethics
EXPECTED CAREER ROADMAP
Potential progression into senior/lead safety medical writing, pharmacovigilance documentation leadership, process excellence, regulatory safety writing expertise and Global Patient Safety leadership roles.
APPLICATION ADVISORY
Highlight 7+ years of pharmacovigilance and medical writing experience; demonstrate expert PSUR, DSUR and RMP knowledge; emphasize regulatory guideline expertise and Health Authority response experience; showcase scientific writing and analytical communication skills; mention AI or structured authoring experience; demonstrate cross-functional leadership and ability to manage complex concurrent projects.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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