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A high-impact opportunity is now open for a Pharmacovigilance (PV) Quality Assurance Principal Scientist with Alphanumeric Systems. This 100% remote job in India offers a chance to work with one of the worldโs leading pharmaceutical organizations, focusing on PV Operations, QMS, CAPA, and compliance excellence.
If you have strong experience in pharmacovigilance case processing, root cause analysis (RCA), CAPA management, and global PV regulations, this role is ideal to transition into PV Quality & Compliance leadership.
๐ Job Overview
- Company: Alphanumeric Systems
- Role: PV Operations QMS Support Principal Scientist
- Location: India (100% Remote)
- Experience: 3โ5 years PV + 1โ2 years QMS
- Employment Type: Full-Time (Fixed Term)
๐ง Key Responsibilities (PV QMS & QA Focus)
- Manage PV non-conformances, deviations, and CAPAs end-to-end
- Conduct Root Cause Analysis (RCA) using structured investigation techniques
- Track CAPAs and ensure timely closure & compliance
- Perform trend analysis, risk indicators, and quality metrics reporting
- Work with Power BI dashboards for metric validation and reconciliation
- Act as SME for GVP, GCP, GMP related to pharmacovigilance
- Support internal & external PV audits and vendor audits
- Collaborate cross-functionally for quality documentation and process improvements
- Ensure data integrity across Argus, Veeva Vault Safety, and QMS systems
- Escalate critical PV issues and contribute to global PV process enhancements
๐ Qualifications & Eligibility
- Education: B.Pharm / M.Pharm / Life Sciences / Nursing / Pharmacology
- Experience:
- 3โ5 years in core Pharmacovigilance (ICSR, case processing)
- 1โ2 years in Quality Management / QMS / CAPA / RCA
๐ก Required Skills (High ATS Match Keywords)
- Pharmacovigilance (PV) Operations
- CAPA Management & Root Cause Analysis (RCA)
- PV Quality Management System (QMS)
- Global PV regulations (FDA, EMA, ICH-GVP)
- Argus Safety Database, Veeva Vault Safety
- Risk assessment & audit readiness
- SOP development & regulatory documentation
- Data integrity & compliance
- Stakeholder & vendor management
๐ฐ Salary Insight (India โ Market Estimate)
- Estimated Salary Range: โน12 LPA โ โน22 LPA
(Based on PV QA Principal Scientist roles, experience, and remote premium)
๐ Why This Role is High-Value
- Work with top global pharma brand (stealth client)
- Transition from PV Operations โ PV Quality Leadership
- Exposure to global audits, compliance frameworks, and vendor oversight
- Fully remote flexibility across India
- High demand skillset: CAPA + RCA + PV QMS
๐ How to Apply
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