Manager – Pharmacovigilance (PSUR / PBRER)
Company: Sun Pharmaceutical Industries Ltd
Business Unit: Global Pharmacovigilance (GPV)
Job Grade: G10
Location: Gurgaon – R&D, India
Job Type: Full-Time
Experience Required: 3–5 Years in Pharmacovigilance
Education: MBBS or MD
Posted On: February 18, 2026
About the Company
Sun Pharmaceutical Industries Ltd is a global specialty pharmaceutical organization committed to patient safety, regulatory excellence, and innovation. The company maintains strong global pharmacovigilance systems aligned with international regulatory standards to ensure continuous benefit-risk evaluation of marketed and investigational products.
Role Overview
The Manager – Pharmacovigilance (PSUR) will be responsible for aggregate safety reporting activities including preparation and review of PSUR/PBRER and related regulatory safety documents. The role requires expertise in benefit-risk evaluation, signal detection, risk characterization, and integration of Individual Case Safety Reports (ICSRs) into cumulative safety assessments for New Chemical Entities (NCEs) and innovator products.
This position plays a critical role in maintaining regulatory compliance and supporting global health authority submissions.
Key Responsibilities
Aggregate Safety Reporting
Prepare and review Periodic Safety Update Reports (PSUR) / Periodic Benefit-Risk Evaluation Reports (PBRER)
Develop summary tabulations and special situation case narratives for aggregate reports
Review published scientific literature relevant to safety reporting
Contribute to DSUR, PADER, Risk Management Plans (RMP), and Safety Management Plans (SMP)
Signal Detection & Risk Assessment
Analyze ICSRs within aggregate contexts, evaluating seriousness, expectedness, and causality
Perform risk characterization and benefit-risk evaluation for NCEs and innovator products
Identify Emerging Safety Issues (ESIs) and Significant Safety Issues (SSIs)
Interpret safety trends and emerging signals across datasets
Regulatory & Clinical Safety Oversight
Review clinical trial protocols from a pharmacovigilance perspective
Evaluate Safety Notifications and contribute to regulatory responses
Support collation and submission of responses to health authority assessment reports
Ensure compliance with global pharmacovigilance regulations and reporting timelines
Technical Expertise
Apply MedDRA coding knowledge in safety data interpretation
Demonstrate strong understanding of regulatory safety documentation requirements
Required Qualifications & Skills
MBBS or MD (Mandatory)
3–5 years of hands-on experience in Pharmacovigilance and Aggregate Safety Reporting
Strong expertise in causality assessment and benefit-risk evaluation
Proficiency in MedDRA coding and safety database interpretation
Experience in preparation/review of PSUR, PBRER, DSUR, PADER, and RMP
Working knowledge of regulatory requirements for NCEs and innovator products
Strong analytical, documentation, and scientific writing skills
Ability to interpret complex safety datasets and regulatory feedback
Work Environment
R&D-based pharmacovigilance role
Cross-functional collaboration with regulatory, clinical, and medical affairs teams
Limited travel as per business requirement
Why Join Sun Pharma
At Sun Pharmaceutical Industries Ltd, pharmacovigilance professionals contribute to safeguarding global patient safety through robust aggregate reporting systems and proactive signal detection strategies. The organization provides opportunities to work on complex global submissions while strengthening regulatory and safety science expertise.
Disclaimer
This job description outlines the general scope of responsibilities. Duties may evolve based on regulatory requirements and business needs. The organization reserves the right to modify or assign responsibilities as appropriate.
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