Safety Surveillance Medical Writing Specialist – Pharmacovigilance
Company: Novo Nordisk
Department: Safety Medical Writing, Safety Surveillance – Global Patient Safety
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Application Deadline: 31 January 2026
Industry: Regulatory Affairs & Pharmacovigilance
Job Overview
Novo Nordisk Global Business Services (GBS) is seeking an experienced Safety Surveillance Medical Writing Specialist to join its Global Patient Safety team in Bengaluru. This senior-level role focuses on delivering high-complexity aggregate safety reports and regulatory pharmacovigilance documents that ensure patient safety and global compliance.
The position offers strategic exposure to global safety reporting processes, health authority interactions, and cross-functional collaboration in a highly regulated pharmaceutical environment.
Experience Required
Minimum 8+ years of experience in pharmacovigilance and medical writing
Proven expertise in aggregate safety reporting and global regulatory submissions
Experience handling high-complexity regulatory documents (e.g., Marketing Authorization Applications) preferred
Exposure to structured authoring tools, artificial intelligence applications, or technical innovations in medical writing is advantageous
Educational Qualification
Master’s degree and/or PhD in Life Sciences (Pharmacy, Medicine, Veterinary Sciences, Biological Sciences, or related discipline)
Key Responsibilities
Prepare complex aggregate safety reports including PSURs, DSURs, and Risk Management Plans (RMPs).
Draft responses to Health Authority queries and ensure regulatory compliance with global guidelines.
Collaborate with cross-functional stakeholders to ensure accurate and timely safety data reporting.
Contribute to evaluation and implementation of evolving global and local pharmacovigilance regulations.
Lead process improvement initiatives and drive innovation within Safety Medical Writing.
Support competency development and mentoring of junior team members.
Apply structured authoring methodologies and technical optimization tools to enhance efficiency and scalability.
Manage multiple high-priority projects while maintaining high-quality scientific standards.
Required Skills & Competencies
Expert knowledge of pharmacovigilance regulations and drug development lifecycle
In-depth understanding of PSUR, DSUR, and RMP preparation guidelines
Strong analytical thinking and scientific data interpretation skills
Excellent written and verbal communication skills in English
Ability to influence stakeholders and lead cross-functional collaboration
Strong project management and multitasking capabilities
High attention to detail with inspection-readiness mindset
About the Department
Safety Medical Writing operates within Global Patient Safety across Bengaluru and Søborg, Denmark. The team is responsible for developing transparent, high-quality pharmacovigilance documentation that communicates product safety profiles to global regulatory authorities.
The department emphasizes ethics, compliance, innovation, and excellence in safety reporting to support regulatory decision-making worldwide.
Why Join Novo Nordisk?
Novo Nordisk is a global leader in chronic disease management with over 100 years of scientific innovation. The organization fosters a culture of collaboration, quality excellence, and patient-centric development while providing opportunities for professional growth within international regulatory frameworks.
Important Notice
Novo Nordisk does not charge any recruitment fees and does not extend unsolicited employment offers. Applicants are advised to verify official communication channels before sharing personal information.
SEO Keywords:
Safety Medical Writing Specialist Jobs India, Pharmacovigilance Jobs Bengaluru, PSUR DSUR RMP Jobs, Novo Nordisk Careers 2026, Global Patient Safety Roles, Regulatory Affairs Safety Jobs, Aggregate Safety Report Writing, Senior PV Medical Writer India.
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