Sun Pharma hiring Pharmacovigilance PSUR role in Gurugram. Apply for aggregate reporting job with ICSR, signal detection and safety expertise.
Introduction
Medical professionals with experience in pharmacovigilance and aggregate safety reporting have a strong career opportunity. Sun Pharmaceutical Industries Ltd is hiring for Pharmacovigilance – PSUR & Aggregate Reporting in Gurugram. This role is ideal for candidates skilled in safety data analysis, risk assessment, and regulatory reporting.
Company Overview
Sun Pharmaceutical Industries Ltd is one of the world’s leading specialty generic pharmaceutical companies and the largest in India. With a global presence across 100+ countries and strong R&D capabilities, Sun Pharma offers excellent opportunities in drug safety, regulatory, and clinical research domains.
Job Location & Employment Type
- Location: Gurugram, Haryana, India
- Job Type: Full-Time, Permanent
- Industry: Pharmacovigilance / Drug Safety / R&D
Job Overview (Job Details Table)
| Job Title | Pharmacovigilance – PSUR & Aggregate |
|---|---|
| Company Name | Sun Pharmaceutical Industries Ltd |
| Qualification | MBBS / MD |
| Experience | 1 – 6 Years |
| Job Location | Gurugram, Haryana |
| Employment Type | Full-Time |
| Salary | Not Disclosed |
| Application Mode | Online Application |
| Department | Pharmacovigilance / Drug Safety |
| Openings | 1 |
Open Positions / Department Details
The position is part of the Pharmacovigilance (Aggregate Reporting) Team, focusing on periodic safety reports such as PSUR/PBRER and overall benefit-risk evaluation of products, especially for New Chemical Entities (NCEs) and innovator drugs.
Key Roles & Responsibilities
As a Pharmacovigilance professional in Aggregate Reporting, your responsibilities will include:
- Analyzing Individual Case Safety Reports (ICSRs) in aggregate context
- Evaluating key safety parameters such as:
- Seriousness
- Expectedness
- Causality
- Contributing to cumulative safety profiles for products
- Performing risk characterization and benefit-risk evaluation
- Reviewing scientific literature for PSUR preparation
- Preparing:
- Summary tabulations
- Special situation case narratives
- Identifying trends and emerging safety signals
- Supporting responses to regulatory authority assessment reports
- Evaluating safety notifications for:
- Emerging Safety Issues (ESIs)
- Significant Safety Issues (SSIs)
- Reviewing clinical trial protocols from a pharmacovigilance perspective
- Reviewing and supporting Safety Management Plans (SMPs)
Eligibility Criteria
Educational Qualification
- MBBS (Mandatory)
- MD (Preferred)
Experience Required
- 1 to 6 years of experience in:
- Pharmacovigilance
- Aggregate reporting
- Drug safety
Skills Required
- Expertise in:
- PSUR / PBRER preparation
- Aggregate reporting
- ICSR analysis
- Knowledge of:
- MedDRA coding
- Regulatory documents (DSUR, PADER, RMP, SMP)
- Strong understanding of:
- Causality assessment
- Signal detection
- Benefit-risk evaluation
- Ability to review clinical trial protocols
- Strong analytical and documentation skills
- Good communication and teamwork abilities
Salary & Benefits
- Salary: Not disclosed (competitive as per experience)
- Opportunity to work with a top global pharma company
- Exposure to advanced pharmacovigilance systems
- Career growth in aggregate reporting and drug safety
- Involvement in global safety evaluation processes
Selection Process
The recruitment process may include:
- Application Screening
- Technical Interview (Pharmacovigilance Focus)
- Case Study / Safety Scenario Evaluation
- HR Discussion
- Final Selection
Candidates with strong aggregate reporting and medical background will be preferred.
How to Apply
Interested candidates should apply through the official Sun Pharma careers portal.
Ensure your resume highlights:
- Pharmacovigilance experience
- PSUR / aggregate reporting expertise
- Medical qualification and regulatory knowledge
Important Dates
- Application Deadline: Not specified (apply as soon as possible)
Why Apply for This Pharma Job?
This role is ideal for medical professionals aiming to grow in pharmacovigilance:
- Work on global safety reporting (PSUR/PBRER)
- Gain expertise in signal detection and risk evaluation
- Exposure to innovator products and NCEs
- Strong career path in drug safety and regulatory science
- Opportunity to work with a leading pharmaceutical company
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with any company or recruiter. Candidates should verify all details independently before applying. We do not charge any fee for job applications.
Final Call-to-Action
If you have a medical background and experience in pharmacovigilance or aggregate reporting, apply at the earliest. This opportunity at Sun Pharma can significantly advance your career in global drug safety and regulatory science.
