Pharmacovigilance Associate (Senior Role)
Pharmacovigilance Associate (Senior Role)
Novo Nordisk
Job description
Want to take your career to the next level in medication safety & pharmacovigilance? Explore the role of Associate Pharmacovigilance Manager at Novo Nordisk India Pvt Ltd, Bangalore, Karnataka.
Company Description
Novo Nordisk is a multinational healthcare corporation, with a purpose to drive change to defeat diabetes and other serious chronic diseases. Its work covers areas such as diabetes, obesity and other critical illnesses. Its pharmacological research, product development and global operations are geared toward improving health outcomes and supporting people living with chronic conditions.
Job Summary
The role of pharmacovigilance associate will be located in Bangalore and will be part of Novo Nordisk India’s Regulatory Affairs and Pharmacovigilance department. The Associate Pharmacovigilance Manager will be responsible for local drug safety processes, individual case safety report (ICSR) management, regulatory submissions and compliance with applicable pharmacovigilance regulations. The function also include audit management, partner coordination, safety data quality assurance and ongoing development of local procedures. The case processing associate will interact with Global Safety, Medical, Clinical, Regulatory and other internal groups as well as outside service providers and business partners.
Key Responsibilities
Responsible for overseeing local pharmacovigilance efforts and guaranteeing compliance with applicable Indian drug safety standards and business processes.
Keep track of changes in local pharmacovigilance requirements, communicate to Global Safety and execute in due time.
Manage the entire Individual Case Safety Report (ICSR) process including case intake, case evaluation, narrative development, quality checks, submission, follow-up and closure with Veeva Safety and Veeva Quality.
Validate information in the safety case against source papers and call records to ensure accurate and comprehensive reporting.
Arrange submissions to health authorities for safety reporting of clinical trials including SUSARs, SAEs and post marketing safety cases.
Support the coordination and review of Periodic Safety Update Reports PSURs .
Handle adverse event information and consumer complaints received by emails, telephone calls, digital apps and internal reporting systems, including documentation and follow-up.
Oversee safety reporting operations, mailbox reconciliation, case follow ups and pharmacovigilance training as per applicable timelines and standard operating procedures.
Liaise with external partners and vendors participating in Client Engagement Programs and Organized Data Collection Systems ensuring relevant safety agreements, training and quality requirements are maintained.
Lead local pharmacovigilance audits and audits with Patient Support Program and Market Research Program partners, including managing the findings and corrective and preventative measures (CAPAs).
Maintain inspection preparedness and help affiliate in any possible or real product recalls.
Identify opportunities to improve pharmacovigilance processes and resolve issues that may impact case processing or submission deadlines.
Educational Qualification
Bachelor’s degree in Pharmacy, Master’s degree in Pharmacy or Doctor of Pharmacy.
At least 7 years of experience in pharmacovigilance, drug safety or a related subject.
Skills Required
Hands on experience in post marketing medication safety case processing and end to end ICSR management.
Knowledge of ICH E2A, E2B(R3) and E2D guidelines.
Knowledge of India’s New Drugs and Clinical Trials Rules, 2019, Pharmacovigilance Program of India (PvPI) guidelines and relevant Good Pharmacovigilance Practices (GVP).
Good knowledge of pharmacovigilance quality systems, regulatory safety reporting and SOP implementation.
Work familiarity with Veeva Safety and Veeva Quality and basic knowledge of MedDRA.
Experience working with cross-functional teams, clients and external partners.
Understanding of scientific ideas and concepts of medication safety.
Skilled with Microsoft Office software.
Excellent writing and spoken communication.
Ability to prioritize competing priorities, fulfil tight deadlines and retain accuracy.
Independent decision making, competent judgment and escalation of possible problems in a timely manner.
Adaptability, Collaboration and Continuous improvement mindset.
Experience in administering Client Engagement Programs and Organized Data Collection Systems.
Salary Structure
The average salary of a Pharmacovigilance Associate (Senior Role) in India is in the range of ₹19 Lakhs - ₹24 Lakhs per year.
Career Development
This post, as a Pharmacovigilance Associate provides an opportunity to build competence in pharmacovigilance compliance, regulatory safety reporting, audit management and quality systems. Working with global and local teams can also develop leadership, stakeholder management and process improvement abilities in drug safety operations.
How to Apply
Search for Pharmacovigilance Associate (Senior Role) on our employment portal.
Open the listing and view the full job description.
Complete the required fields and upload your updated resume.
Apply through the official recruitment portal.
The application deadline is 30 October 2026.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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