Safety Surveillance Medical Writing Specialist – Pharmacovigilance
Category: Regulatory Affairs & Safety – Pharmacovigilance
Location: Bangalore, Karnataka, India
Department: Safety Medical Writing, Safety Surveillance, Global Patient Safety
Company: Novo Nordisk
Application Deadline: 31 January 2026
Job Overview
Novo Nordisk is seeking an experienced Safety Surveillance Medical Writing Specialist to join the Global Patient Safety team in Bangalore. This senior-level role focuses on high-complexity pharmacovigilance documentation, aggregate safety reporting, and regulatory compliance to ensure patient safety across global markets.
The position is ideal for seasoned pharmacovigilance professionals with deep expertise in safety surveillance, regulatory medical writing, and risk management documentation within pharmaceutical drug development.
Key Responsibilities
Prepare and lead the development of complex aggregate safety reports, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
Draft and coordinate responses to Health Authority queries related to safety surveillance and benefit-risk evaluation.
Collaborate with cross-functional stakeholders across Safety Surveillance, Clinical Development, Regulatory Affairs, and Medical Affairs to ensure high-quality and timely safety documentation.
Evaluate and implement updates in local and global pharmacovigilance regulations and guidelines to maintain compliance.
Contribute to innovation initiatives, including structured authoring, AI-supported medical writing, and technical optimization projects.
Drive continuous process improvements and competency development within the Safety Medical Writing function.
Act as a subject matter expert and mentor for junior medical writers, ensuring document quality and regulatory alignment.
Manage multiple high-complexity deliverables while maintaining strict timelines and quality standards.
Required Qualifications and Experience
Master’s degree and/or PhD in Life Sciences (Pharmacy, Medicine, Veterinary Sciences, Biological Sciences, or related field).
Minimum 8+ years of experience in pharmacovigilance and regulatory medical writing within the pharmaceutical industry.
Strong expertise in PSURs, DSURs, RMPs, and global pharmacovigilance regulations.
Solid understanding of drug development lifecycle and safety surveillance processes.
Experience handling high-complexity regulatory documents, including Marketing Authorization Application (MAA) submissions (preferred).
Demonstrated experience in applying AI tools, structured authoring systems, or digital optimization solutions in medical writing.
Strong analytical, scientific writing, and data interpretation skills.
Proven ability to lead cross-functional collaborations and advise stakeholders on document structure and regulatory compliance.
Excellent written and verbal English communication skills.
Ability to manage multiple projects simultaneously in a global matrix environment.
About the Safety Medical Writing Team
The Safety Medical Writing function operates within Global Patient Safety, with teams based in Bangalore and Søborg. The department is responsible for delivering regulatory pharmacovigilance documentation that ensures transparent, ethical, and compliant communication of product safety data worldwide.
The team plays a critical role in presenting safety information clearly and accurately to health authorities, regulatory agencies, and internal stakeholders to support global patient safety commitments.
Why Join Novo Nordisk?
With more than 100 years of leadership in chronic disease innovation, Novo Nordisk continues to set global standards in patient safety, regulatory excellence, and scientific integrity. Employees benefit from working in a purpose-driven organization that values collaboration, innovation, and continuous improvement in global healthcare delivery.
This role offers the opportunity to shape global pharmacovigilance documentation strategy and contribute directly to safeguarding patient health worldwide.
Application Process
Interested candidates should apply online by submitting an updated CV before 31 January 2026.
Novo Nordisk follows a transparent recruitment process and does not request fees or payments at any stage of hiring.
Equal Opportunity Statement
Novo Nordisk is committed to an inclusive recruitment process and equal opportunity for all applicants.
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