The pharmaceutical safety domain continues to expand as global regulatory authorities strengthen drug monitoring requirements. A new opportunity has opened for a Research Scientist – Pharmacovigilance in Sector 32, Gurugram, offering an excellent platform for professionals looking to grow in drug safety, ICSR processing, and global PV operations.
This role is ideal for candidates with hands-on exposure to case processing, MedDRA coding, narrative writing, and regulatory compliance, who are seeking to advance their careers in pharmacovigilance and patient safety.
🔬 Job Overview
- Role: Research Scientist – Pharmacovigilance
- Location: Sector 32, Gurugram, Haryana
- Qualification: M.Pharm / Pharm D (Mandatory)
- Experience: 1 to 2.5 Years in Pharmacovigilance / PV Operations
- Employment Type: Full-Time
- Industry: Drug Safety / Pharmacovigilance / Clinical Research
🧾 Key Responsibilities
The selected candidate will contribute to global pharmacovigilance activities, ensuring compliance with international safety regulations.
- Perform duplicate checks, triage, and accurate ICSR data entry as per global PV guidelines.
- Conduct quality control (QC) review, including MedDRA and WHO-DD coding validation.
- Prepare and review clinical narratives, expectedness evaluation, and causality assessment.
- Manage case allocation workflows to meet regulatory timelines and internal KPIs.
- Review and validate follow-up requests to ensure complete case documentation.
- Support global regulatory submissions in compliance with GVP guidelines.
- Ensure adherence to SOPs, PV regulations, and quality standards.
- Assist during audits, inspections, and process improvement initiatives.
- Mentor junior team members to maintain high-quality pharmacovigilance output.
🎓 Eligibility Criteria
Educational Qualification
- M.Pharm (Pharmacology / Pharmacy Practice / Clinical Pharmacy preferred)
- Pharm D (Doctor of Pharmacy)
Experience Required
- 1–2.5 years of experience in:
- ICSR Case Processing
- Pharmacovigilance Operations
- Drug Safety Data Management
- MedDRA Coding & Narrative Writing
- Global Safety Databases (Argus/ArisG preferred)
💼 Desired Skills
- Strong understanding of ICH-GVP guidelines and global PV regulations
- Knowledge of signal detection principles and regulatory timelines
- Excellent attention to detail and medical documentation accuracy
- Ability to work in high-volume case environments
- Strong analytical and compliance-driven mindset
- Effective collaboration with cross-functional safety teams
💰 Salary & Benefits (Estimated)
- Expected Salary Range: ₹5.5 LPA – ₹8.0 LPA (Based on experience and PV expertise)
- Exposure to global pharmacovigilance systems and regulatory frameworks
- Career progression into Drug Safety Scientist / PV Specialist roles
- Opportunity to participate in audits, inspections, and international submissions
📩 How to Apply
Interested candidates can share their updated resume via email:
Email: sonia.kaushik@ext.fresenius-kabi.com
Subject Line: Application for RS – ICSR Role
Applicants may also connect with the hiring team members for faster consideration.
