Safety Survey Medical Writing Specialist
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Bangalore • India
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About the role
- Be responsible for the preparation of complex aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority questions
- Collaborate with cross-functional teams to ensure high-quality scientific writing and timely reporting of safety data
- Contribute to the evaluation and implementation of changes in local/global guidelines to ensure compliance with internal and external requirements
- Contribute to innovation and technical optimization projects within Safety Medical Writing to enhance efficiency, quality, and scalability of deliverables
- Drive process improvement activities, medical writing competency development and skill building across Safety Medical Writing.
- Act as an expert for junior team members, share information, and take proactive steps to excel in your role.
Requirements
- A master’s degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological)
- Proven experience (>8 years working within pharmacovigilance and medical writing)
- Excellent analytical and communication skills
- Solid understanding of pharmacovigilance and of drug development in general
- Expert understanding of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) and RMPs, and the guidelines and regulations that drive their preparation
- Experience in applying artificial intelligence/structured authoring or other technical solutions in medical writing
- Highly collaborative, capable of leading cross-functional team members
- Able to handle multiple projects simultaneously and deliver multiple high-quality documents on schedule
- Fluency in both written and spoken English (business language)
Benefits
- Health insurance
- Flexible working arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancemedical writinganalytical skillsscientific writingPeriodic Safety Update Reports (PSURs)Development Safety Update Reports (DSURs)Risk Management Plans (RMPs)artificial intelligencestructured authoringdrug development
Soft Skills
communication skillscollaborationleadershipproject managementtime managementmentoringproblem-solvingadaptabilityattention to detailproactivity
Certifications
master’s degreePhD