Safety Surveillance Adviser – Pharmacovigilance & Drug Safety
Location: Bengaluru, Karnataka, India
Department: Global Patient Safety (GPS)
Company: Novo Nordisk Global Business Services (GBS)
Employment Type: Full-Time
Job Overview
Novo Nordisk is seeking a highly skilled Safety Surveillance Adviser to join its Global Patient Safety team in Bengaluru. This role is critical in establishing and maintaining the safety profile of pharmaceutical products across both development and post-marketing stages. The position involves continuous safety surveillance, regulatory communication, and contribution to risk-benefit evaluation to ensure patient safety and compliance with global regulatory standards.
Key Responsibilities
Lead safety surveillance activities across the product lifecycle, including pre-approval and post-marketing phases. Establish and maintain safety sections of Company Core Data Sheets (CCDS) and ensure accurate labeling for marketed products. Prepare and review aggregate safety reports including DSURs, PSURs, SUSAR reports, and Risk Management Plans (RMPs) in accordance with regulatory requirements. Provide strategic safety input into clinical documents such as protocols, investigator brochures, clinical trial reports, and product development plans.
Act as a key contributor to cross-functional safety committees by presenting safety data analyses and supporting decision-making. Monitor, evaluate, and communicate safety signals from global data sources, ensuring timely reporting to health authorities and internal stakeholders. Respond to safety-related queries from regulatory authorities, ethics committees, and internal teams. Support Data Monitoring Committees (DMCs) and contribute to investigator training on safety-related aspects. Participate in labeling change requests and provide expert safety input for regulatory updates.
Eligibility Criteria
Candidates must hold an MBBS with MD (preferred) or equivalent medical qualification.
Experience Required:
Minimum 3 to 6 years of relevant experience in pharmacovigilance, including signal management, aggregate reporting, and Individual Case Safety Report (ICSR) processing.
Required Skills & Competencies
Strong expertise in pharmacovigilance processes including signal detection, risk management, and aggregate safety reporting. In-depth understanding of global regulatory requirements and drug safety guidelines. Proficiency in Microsoft Office tools including Word, Excel, PowerPoint, and Outlook. Excellent analytical, communication, and stakeholder management skills. Ability to work in a dynamic, cross-functional, and global environment with evolving priorities.
About the Team
The Global Patient Safety team at Novo Nordisk plays a vital role in ensuring the safety of products across therapeutic areas such as diabetes, obesity, and rare diseases. The team collaborates closely with global stakeholders and contributes to maintaining a favorable benefit-risk balance for patients worldwide.
Why Join Novo Nordisk
Opportunity to work with a globally recognized leader in healthcare and pharmacovigilance. Exposure to global safety surveillance systems and regulatory frameworks. Collaborative, innovation-driven environment focused on patient safety and scientific excellence. Strong career growth and continuous learning opportunities within a global organization.
Application Deadline: 08 April 2026
About Novo Nordisk
Novo Nordisk is a leading global healthcare company with over a century of innovation in addressing chronic diseases. The organization is committed to improving patient lives through scientific excellence, ethical practices, and continuous advancement in healthcare solutions.
Equal Opportunity Statement
Novo Nordisk is an equal opportunity employer committed to diversity and inclusion, ensuring fair and unbiased hiring practices for all applicants.
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