Elite Biopharma is hiring for Drug Safety and Pharmacovigilance positions in Hyderabad, including opportunities for experienced professionals and freshers. The openings cover ICSR Processing and Aggregate Reporting within the Pharmacovigilance function.
Job Details
| Job Details | Information |
|---|---|
| Company | Elite Biopharma |
| Department | Pharmacovigilance |
| Location | Hyderabad |
| Employment Type | Full-Time |
| Job Areas | Drug Safety, Pharmacovigilance, ICSR Processing, Aggregate Reporting |
Positions
1. Drug Safety Scientist – ICSR Process
Experience: 6 years
Location: Hyderabad
The role involves end-to-end processing of Individual Case Safety Reports (ICSRs), from intake through case closure.
Responsibilities
- Process ICSRs from receipt to case closure
- Perform case intake, triage, duplicate checks, data entry, and case assessment
- Perform seriousness, expectedness, and causality assessment
- Review and code adverse events using MedDRA
- Perform drug coding and medical review of cases
- Prepare and submit safety reports within applicable timelines
- Handle follow-up activities and obtain missing information
- Maintain accurate and complete case documentation
- Perform quality control and maintain compliance with PV SOPs and regulatory requirements
- Support process improvement and quality initiatives
Eligibility
- B.Pharm, M.Pharm, Pharm.D, Life Sciences, or related qualification
- 6 years of relevant Pharmacovigilance or Drug Safety experience
- Hands-on experience in ICSR processing
Required Skills
- Knowledge of global Pharmacovigilance regulations and reporting requirements
- Experience with safety databases and MedDRA coding
- Strong analytical, documentation, and communication skills
2. Drug Safety Associate – Aggregate Reporting
Experience: Fresher / Entry Level
Location: Hyderabad
This position provides entry-level exposure to Aggregate Reporting, safety data analysis, signal detection, regulatory reporting, and global Pharmacovigilance operations.
Responsibilities
- Support preparation and review of aggregate safety reports
- Assist with PSUR/PBRER and DSUR activities
- Support collection and review of cumulative safety data
- Assist in safety data analysis and reconciliation
- Support preparation of safety report sections and documentation
- Assist with literature and safety information review
- Support signal detection and safety surveillance activities
- Coordinate with internal teams for required safety data
- Follow applicable SOPs, regulatory requirements, timelines, and quality standards
Eligibility
- Pharm.D
- B.Sc / M.Sc in Life Sciences or related fields
Preferred Skills
- Basic understanding of Pharmacovigilance and Aggregate Reporting
- Knowledge of PSUR/PBRER, DSUR, and safety surveillance concepts
- Understanding of medical and pharmaceutical terminology
- Strong analytical and attention-to-detail skills
- Good written and verbal communication
- Good documentation skills
- Willingness to learn global PV processes and regulatory requirements
3. Drug Safety Associate – ICSR Processing
Experience: Fresher / Entry Level
Location: Hyderabad
The position focuses on supporting ICSR processing, case management, medical coding, safety reporting, and Pharmacovigilance operations.
Responsibilities
- Support ICSR case intake and processing
- Perform case data entry and documentation
- Review and assess information from AE/ADR reports
- Perform medical coding using applicable coding conventions
- Assist with case narrative preparation
- Support case follow-up and query management
- Perform duplicate case checks
- Assist with case quality review and reconciliation
- Follow applicable SOPs, timelines, and quality requirements
- Maintain confidentiality and accuracy of patient safety information
Eligibility
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc / M.Sc in Life Sciences or related fields
Preferred Skills
- Basic understanding of Pharmacovigilance and ICSR concepts
- Knowledge of medical terminology
- Good written and verbal communication
- Strong attention to detail
- Good analytical and documentation skills
- Ability to work within defined timelines
- Willingness to learn PV processes and safety databases
Application Details
Interested candidates can share their updated CV/resume or connect with Elite Biopharma regarding the opportunities.
Email: info@elitebiopharma.com
