Soterius is a leading name in the pharmaceutical and life sciences industry, specializing in pharmacovigilance, regulatory compliance, and drug safety solutions. With a commitment to excellence, we provide robust pharmacovigilance services to ensure patient safety and regulatory adherence. Join our dynamic team in Ahmedabad and contribute to global healthcare safety standards.
Detailed Job Description
Position: Quality Reviewer – Pharmacovigilance
Location: Ahmedabad
Job Type: Full-time
Industry: Pharmaceutical / Healthcare / Life Sciences
Key Responsibilities:
- Conduct quality reviews of Individual Case Safety Reports (ICSRs) to ensure compliance with global pharmacovigilance regulations (FDA, EMA, WHO, etc.).
- Perform data accuracy checks for adverse event reports, ensuring consistency with source documents.
- Identify and document discrepancies, providing feedback to case processing teams.
- Ensure adherence to SOPs, ICH-GCP, and regulatory guidelines.
- Support audit readiness activities and participate in CAPA implementation.
- Collaborate with pharmacovigilance teams to enhance case processing efficiency.
Eligibility Criteria
Educational Qualification:
- M.Pharm / B.Pharm / BDS / PharmD (Preferred)
Experience Required:
- Minimum 2 years in Quality Review of ICSR case processing.
- Strong knowledge of Argus, VigiFlow, or other safety databases (preferred).
- Familiarity with MedDRA and WHO-DD coding.
Skills & Competencies:
- Attention to detail & strong analytical skills.
- Knowledge of global pharmacovigilance regulations.
- Excellent communication and documentation abilities.
Benefits & Perks
✅ Competitive salary & performance incentives
✅ Health insurance & wellness programs
✅ Professional development & training opportunities
✅ Collaborative work environment
✅ Flexible work policies (if applicable)
How to Apply
Interested candidates meeting the criteria can share their resume at hr@soterius.com with the subject line: “Application for Quality Reviewer – Pharmacovigilance”.
📩 Email: hr@soterius.com
📍 Location: Ahmedabad, India
