Safety Surveillance Medical Writing Specialist Jobs at Novo Nordisk focusing on pharmacovigilance reports, RMPs, PSURs, and global safety compliance.
Safety Surveillance Medical Writing Specialist
Category: Regulatory Affairs & Safety Pharmacovigilance
Team: Safety Medical Writing, Safety Surveillance, Global Patient Safety
Location: Bangalore, Karnataka, India
Work Location: Novo Nordisk Global Business Services (GBS), India
Application Deadline: 31 January 2026
About the Company
Novo Nordisk is a global healthcare leader with more than a century of experience in discovering and developing innovative medicines. Driven by a clear purpose—to defeat serious chronic diseases—the company continuously pushes scientific boundaries to improve patient lives worldwide.
Novo Nordisk is known for its strong ethical foundation, transparency, and long-term vision. With operations across the globe, the organization fosters a collaborative and inclusive culture where diverse perspectives, scientific curiosity, and innovation come together to create sustainable healthcare solutions. Employees at Novo Nordisk are united by a shared mission and empowered to make a meaningful impact on patients, healthcare systems, and society. Safety Surveillance Medical Writing Specialist Jobs
Job Overview
The Safety Surveillance Medical Writing Specialist role is a senior-level position within Global Patient Safety, based in Bangalore. This role is designed for experienced pharmacovigilance and medical writing professionals who can independently manage high-complexity safety documents and provide scientific leadership within the team. Safety Surveillance Medical Writing Specialist Jobs
The position plays a critical role in ensuring that safety data for Novo Nordisk products is communicated clearly, accurately, and in compliance with global regulatory requirements. It involves close collaboration with cross-functional stakeholders and contribution to continuous improvement and innovation within safety medical writing. Safety Surveillance Medical Writing Specialist Jobs
This opportunity is ideal for professionals seeking senior pharmacovigilance medical writing jobs, safety surveillance roles, or regulatory safety documentation careers in a global pharmaceutical organization.
The Position
As a Safety Medical Writing Specialist, you will take ownership of complex regulatory safety documents and act as a subject matter expert within Safety Medical Writing. The role combines scientific expertise, regulatory knowledge, leadership, and innovation to ensure high-quality safety deliverables. Safety Surveillance Medical Writing Specialist Jobs
You will be responsible for preparing aggregate safety reports and risk management documentation while ensuring alignment with evolving global and local regulatory guidelines. In addition to document authoring, you will contribute to process optimization, capability building, and mentoring of junior colleagues within the team. Safety Surveillance Medical Writing Specialist Jobs
Key Responsibilities
- Prepare complex aggregate safety reports, including PSURs, DSURs, and other regulatory safety documents
- Author and maintain Risk Management Plans (RMPs) and respond to Health Authority questions
- Ensure high-quality, accurate, and timely delivery of safety documents
- Collaborate with cross-functional stakeholders to align on scientific content and regulatory expectations
- Evaluate and implement changes in local and global safety regulations and guidelines
- Ensure compliance with internal standards and external regulatory requirements
- Contribute to innovation, automation, and technical optimization initiatives within Safety Medical Writing
- Support process improvement activities to enhance efficiency, quality, and scalability
- Act as an expert resource and mentor for junior team members
- Share knowledge, best practices, and proactively support team capability development
- Manage multiple high-complexity projects simultaneously while meeting strict timelines
Safety Surveillance Medical Writing Specialist Jobs
Qualifications
Educational Background
- Master’s degree and/or PhD in Life Sciences such as Pharmacy, Medicine, Veterinary Sciences, or Biological Sciences
Experience
- More than 8 years of proven experience in pharmacovigilance and medical writing
- Experience handling complex regulatory safety documents and submissions
Technical Expertise
- Expert-level understanding of PSURs, DSURs, RMPs, and related global guidelines
- Strong knowledge of pharmacovigilance processes and drug development lifecycle
- Experience with high-complexity documents such as Marketing Authorization Applications is an advantage
- Exposure to artificial intelligence, structured authoring, or other technical solutions in medical writing
Core Skills
- Excellent analytical and scientific writing skills
- Strong verbal and written communication skills
- Ability to advise on document structure, content, and regulatory strategy
- Capability to lead cross-functional discussions and negotiate solutions
- Proven ability to manage multiple priorities and deliver high-quality outputs on schedule
- Fluency in written and spoken English as a business language
About the Department
Safety Medical Writing is a global function within Global Patient Safety, with teams based in Bangalore, India, and Søborg, Denmark. The department provides specialized expertise in regulatory pharmacovigilance documentation to support Novo Nordisk products across their lifecycle. Safety Surveillance Medical Writing Specialist Jobs
The team ensures that safety data is presented clearly, concisely, and ethically in documents that meet regulatory expectations and are fit for purpose. Transparency, scientific integrity, and patient safety are the core principles guiding all deliverables produced by the department. Safety Surveillance Medical Writing Specialist Jobs
Working at Novo Nordisk
Working at Novo Nordisk means being part of a company that thinks long-term and acts with purpose. For over 100 years, the organization has been driven by curiosity, determination, and an unconventional approach to solving complex healthcare challenges.
Employees are encouraged to challenge assumptions, explore bold ideas, and collaborate across disciplines. Novo Nordisk values respect, inclusion, and shared responsibility, creating an environment where individuals can grow professionally while contributing to a legacy of global health impact.
When you join Novo Nordisk, you become part of a mission that goes beyond short-term results, focusing instead on creating lasting change for patients and future generations. Safety Surveillance Medical Writing Specialist Jobs
Why You Should Join
This role offers an opportunity to work at the highest level of safety medical writing within a globally respected pharmaceutical company. You will gain exposure to complex safety surveillance activities, global regulatory interactions, and innovation initiatives shaping the future of pharmacovigilance documentation. Safety Surveillance Medical Writing Specialist Jobs
The position allows you to influence processes, mentor others, and contribute strategically to patient safety while working in a collaborative and purpose-driven environment. For experienced medical writers looking to advance their careers, this role provides both challenge and long-term professional fulfillment. Safety Surveillance Medical Writing Specialist Jobs
How to Apply
Interested candidates should apply online through the official Novo Nordisk career portal.
Novo Nordisk does not charge any fees at any stage of the recruitment process. Applicants are advised to remain vigilant against fraudulent job offers and communicate only through official channels.
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