Job Description: Jr. Associate – Pharmacovigilance
Company: Novo Nordisk India Pvt. Ltd. Department: Regulatory Affairs & Safety – Pharmacovigilance Job Location: Bangalore, Karnataka, India Role: Jr. Associate – Pharmacovigilance Application Deadline: 20 November 2026
1. About the Role
As a Jr. Associate – Pharmacovigilance at Novo Nordisk, you will play an important role in ensuring the timely and accurate processing of safety information related to pharmaceutical products.
You will be responsible for processing Adverse Events (AEs), Product Quality Complaints (PQCs), and supporting timely safety reporting to local Health Authorities. You will also maintain accurate pharmacovigilance records and ensure compliance with applicable regulatory requirements.
Working as part of the International Operations team, you will contribute to the overall safety monitoring of Novo Nordisk products and support global pharmacovigilance activities.
2. Educational Qualifications
Bachelor's degree in Pharmacy (B. Pharm).
Master's degree in Pharmacy (M. Pharm) or Doctor of Pharmacy (PharmD) is preferred.
3. Experience and Technical Requirements
1–2 years of experience in Pharmacovigilance or Drug Safety is preferred.
Training in pharmacovigilance fundamentals and safety databases is an added advantage.
Basic understanding of:
Pharmacovigilance processes.
Adverse Event (AE) reporting.
Individual Case Safety Report (ICSR) processing.
Regulatory guidelines and requirements.
Familiarity with Veeva Safety and Veeva Quality is preferred.
Proficiency in Microsoft Office applications.
Fluency in English, with good written and verbal communication skills.
4. Regulatory Knowledge Required
Candidates should have a basic understanding of the following regulatory guidelines:
ICH Guidelines (International Council for Harmonisation).
New Drugs and Clinical Trials Rules, 2019 (NDCT).
Pharmacovigilance Programme of India (PvPI) Guidelines.
Applicable Good Pharmacovigilance Practices (GVP).
5. Key Roles and Responsibilities
A. Adverse Event and Product Quality Complaint Management
Receive, document and report Adverse Events (AEs).
Process Product Quality Complaints (PQCs).
Handle Adverse Events associated with Product Quality Complaints.
Forward safety information to Global Safety within the required timelines.
Perform follow-ups and ensure cases are tracked until closure.
B. Safety Information Collection and Intake
Monitor the pharmacovigilance safety mailbox.
Handle safety information and customer complaints received through:
Phone calls.
Digital applications.
Internal safety portals.
Other communication channels.
Ensure accurate documentation of incoming safety information.
C. ICSR Processing and Case Management
Perform assigned activities throughout the Individual Case Safety Report (ICSR) lifecycle.
Work with Veeva Safety and Veeva Quality databases.
Support activities such as:
Case intake and initial assessment.
Case narrative preparation.
Quality review.
Regulatory submission.
Follow-up activities.
Case closure.
D. Quality Control and Data Verification
Perform quality checks on pharmacovigilance cases.
Conduct Source Data Verification (SDV).
Perform data reconciliation activities.
Ensure case information is accurate, complete and consistent.
Identify discrepancies and escalate issues when required.
E. Regulatory Reporting and Submission
Support the preparation and submission of clinical trial safety reports.
Assist with reporting of:
Serious Adverse Events (SAEs).
Suspected Unexpected Serious Adverse Reactions (SUSARs).
Post-marketing Individual Case Safety Reports (ICSRs).
Support timely reporting to local Health Authorities.
Track regulatory submissions and ensure compliance with reporting timelines.
F. Pharmacovigilance Documentation and Compliance
Maintain pharmacovigilance safety databases.
Update safety submission trackers.
Maintain accurate and complete PV documentation.
Ensure records are readily accessible for audits and inspections.
Support compliance monitoring activities.
G. Regulatory Intelligence and Local PV Requirements
Monitor applicable local pharmacovigilance regulatory requirements.
Identify new or amended regulatory requirements.
Communicate relevant regulatory updates to Global Safety.
Track compliance-related activities.
Identify and escalate potential delays or compliance issues.
6. Required Skills and Competencies
Basic knowledge of pharmacovigilance and drug safety processes.
Understanding of AE, SAE, SUSAR, PQC and ICSR reporting.
Knowledge of pharmacovigilance regulatory guidelines.
Familiarity with Veeva Safety and Veeva Quality.
Strong attention to detail and accuracy.
Good written and verbal communication skills.
Excellent documentation and record-management skills.
Ability to prioritise tasks and manage multiple responsibilities.
Ability to meet strict regulatory reporting timelines.
Teamwork and collaboration skills.
Ability to identify and escalate issues promptly.
Proficiency in Microsoft Office.
7. Key Stakeholders and Departments
The Jr. Associate – Pharmacovigilance will work closely with the following teams:
Global Safety: Reporting adverse events and sharing safety information within required timelines.
Clinical Department: Supporting clinical trial safety reporting and related PV activities.
Regulatory Affairs: Coordinating regulatory reporting and compliance requirements.
Medical Department: Collaborating on safety-related medical information.
Local Pharmacovigilance Team: Supporting daily PV operations and case management.
Customers: Communicating directly when collecting safety information and handling product complaints.
8. Training and Career Development
Novo Nordisk provides opportunities to develop practical knowledge and expertise in pharmacovigilance.
Employees can expect:
Hands-on experience with safety databases.
Practical exposure to ICSR processing and case management.
Training in pharmacovigilance regulatory requirements.
Guidance and support from experienced pharmacovigilance professionals.
Opportunities to strengthen technical and professional skills.
Structured learning and development opportunities.
9. Important Application Details
|
Particulars |
Details |
|---|---|
|
Company |
Novo Nordisk India Pvt. Ltd. |
|
Job Title |
Jr. Associate – Pharmacovigilance |
|
Department |
Regulatory Affairs & Safety |
|
Functional Area |
Pharmacovigilance |
|
Location |
Bangalore, Karnataka, India |
|
Preferred Qualification |
B. Pharm / M. Pharm / PharmD |
|
Preferred Experience |
1–2 Years |
|
Application Deadline |
20 November 2026 |
10. Overall Job Objective
The primary objective of this role is to ensure the accurate collection, documentation, processing and timely reporting of adverse events and product quality complaints.
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