Job Title: Pharmacovigilance (PV) Quality Assurance Principal Scientist

Job Summary

Alphanumeric Systems is seeking a highly skilled and detail-oriented Principal Scientist to join our team as a Pharmacovigilance (PV) Operations QMS Support lead. This is a 100% remote position based in India, offering the unique opportunity to support a leading global pharmaceutical organization. The ideal candidate will bridge the gap between PV operations and quality assurance, focusing on process excellence, regulatory compliance, and robust CAPA management. If you are an experienced PV professional looking to transition into a leadership-focused quality and compliance role, this position offers significant professional growth within a high-impact global framework.

Job Overview

• Company: Alphanumeric Systems
• Role: PV Operations QMS Support Principal Scientist
• Location: 100% Remote (India)
• Employment Type: Full-Time (Fixed Term)

Key Responsibilities

In this role, you will play a critical part in maintaining the integrity and compliance of our global pharmacovigilance operations. Your primary responsibilities will include:

• CAPA & Deviation Management: Oversee the end-to-end lifecycle of PV non-conformances, deviations, and Corrective and Preventive Actions (CAPA).
• Root Cause Analysis (RCA): Apply structured investigation techniques to identify root causes of incidents and implement sustainable corrective measures.
• Compliance & Monitoring: Track CAPA timelines to ensure timely closure and adherence to global PV regulations. Perform trend analysis, identify quality risk indicators, and generate metrics reports.
• Data & System Integrity: Utilize Power BI dashboards for metric validation and reconciliation, ensuring data accuracy across Argus, Veeva Vault Safety, and other QMS systems.
• Subject Matter Expertise: Serve as an SME for GVP, GCP, and GMP standards as they relate to pharmacovigilance.
• Audit Readiness: Actively support internal, external, and vendor-related PV audits, ensuring all documentation is ready for regulatory scrutiny.
• Process Improvement: Collaborate with cross-functional teams to refine PV processes, update Standard Operating Procedures (SOPs), and drive global process enhancements.
• Escalation: Monitor and escalate critical PV issues to leadership, providing data-driven recommendations for resolution.

Qualifications & Requirements

To be successful in this role, candidates must possess a strong foundation in clinical safety and a keen eye for quality detail:

• Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or Pharmacology.
• Professional Experience:
  • 3–5 years of experience in core Pharmacovigilance (ICSR/Case Processing).
  • 1–2 years of focused experience in Quality Management Systems (QMS), CAPA, or RCA.
• Technical Proficiency: Advanced knowledge of Argus Safety Database and Veeva Vault Safety.
• Regulatory Knowledge: Deep understanding of global PV regulations, including FDA, EMA, and ICH-GVP guidelines.
• Analytical Skills: Proven ability to perform risk assessments, interpret complex data, and maintain high standards of documentation integrity.
• Communication: Excellent stakeholder and vendor management skills to facilitate effective cross-functional collaboration.

Why This Role is High-Value

This position is designed for professionals who want to elevate their careers beyond standard case processing. By joining this project, you will:

• Gain exposure to the high-stakes environment of a top-tier global pharmaceutical brand.
• Develop specialized expertise in the intersection of PV Operations and Quality Leadership.
• Operate with full remote flexibility, allowing you to manage global compliance frameworks from anywhere in India.
• Utilize high-demand, niche skills (CAPA, RCA, and QMS) that are essential in the modern pharmaceutical regulatory landscape.

Salary Insight

The estimated salary range for this position is ₹12 LPA – ₹22 LPA, commensurate with experience, technical expertise, and the specialized nature of the role.

How to Apply

If you meet the requirements and are ready to take the next step in your PV Quality and Compliance career, please submit your application through our official portal below:

Click Here to Apply for the PV QA Principal Scientist Position