G S S Pharma is a reputed pharmaceutical company with a strong focus on drug safety and regulatory compliance. With a rating of 4.1 (based on 127 reviews), the company is known for its commitment to pharmacovigilance (PV) and patient safety. Located in Whitefield, Bengaluru, G S S Pharma offers a dynamic work environment for professionals looking to grow in the pharmaceutical and drug safety sectors.
Detailed Job Description
1. Pharmacovigilance Associate (1-2 Years Experience)
Role & Responsibilities:
- Process Individual Case Safety Reports (ICSRs) and conduct literature screening.
- Review and validate literature abstracts/articles for safety database entry.
- Maintain XEVMPD (Extended Eudravigilance Medical Product Dictionary) and perform EVWEB updates.
- Prepare and revise Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PILs).
- Conduct comparative reviews of SmPCs & PILs against reference products.
- Develop and maintain Risk Management Plans (RMPs) with risk mitigation strategies.
- Monitor safety updates & signals for compliance with SOPs & regulatory guidelines.
Preferred Candidate Profile:
- Experience in Eudravigilance, XEVMPD maintenance, and EVWEB updates.
- Knowledge of SmPC, PIL, and regulatory documentation.
- Familiarity with ICSR processing and reference product comparisons.
2. Pharmacovigilance Senior Associate (2-3 Years Experience)
Role & Responsibilities:
- Hands-on experience in ICSR processing & literature screening.
- Maintain XEVMPD and perform EVWEB updates (SmPC/PIL revisions).
- Prepare Risk Management Plans (RMPs) and ensure regulatory compliance.
- Monitor safety signals and ensure adherence to SOPs & global PV regulations.
Preferred Candidate Profile:
- Strong expertise in Eudravigilance, XEVMPD, and regulatory documentation.
- Experience in SmPC/PIL comparisons and ICSR case processing.
Eligibility & Skills Required
- Education: Degree in Pharmacy, Life Sciences, or related fields.
- Experience: 1-3 years in pharmacovigilance, drug safety, or regulatory affairs.
- Technical Skills:
- Proficiency in Eudravigilance & XEVMPD.
- Knowledge of ICSR processing (Argus/ArisG/Vigibase).
- Understanding of EU PV regulations & ICH-GCP guidelines.
Benefits & Work Culture
✅ Competitive salary (based on experience)
✅ Health & wellness benefits
✅ Opportunities for career growth in pharmacovigilance
✅ Work in a regulatory-compliant, safety-focused environment
How to Apply
📌 Location: Whitefield, Bengaluru
📌 Openings:
- Pharmacovigilance Associate: 2 openings
- Senior Associate: 1 opening
Application Link for Pharmacovigilance Associate
Application Link for PV Senior Associate
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