Pharmacovigilance Operations QMS Support Principal Scientist

Why This Role Matters
The PV Operations QMS Support Principal Scientist plays a vital role in maintaining the integrity and effectiveness of pharmacovigilance quality systems. By ensuring proper management of deviations, CAPAs, and audit findings, this role directly supports regulatory compliance and patient safety. It helps organizations maintain high standards in drug safety operations, reduce risks, and continuously improve pharmacovigilance processes on a global scale.

Job Description
The PV Operations QMS Support Principal Scientist at Alphanumeric Systems is responsible for supporting and enhancing Pharmacovigilance Quality Management Systems (QMS). The role focuses on managing quality events, performing root cause analysis, tracking CAPAs, and ensuring compliance with global regulatory standards. This is a fully remote role based in India, offering exposure to global PV operations and quality assurance activities.

Key Features of the Role:
• 100% remote opportunity with global exposure
• Core involvement in PV Quality Management System (QMS) operations
• Hands-on experience in CAPA, RCA, and audit support
• Interaction with global stakeholders and PV vendors
• High-impact role in ensuring regulatory compliance and quality excellence

Responsibilities
• Manage PV deviations, non-conformances, and CAPAs from initiation to closure
• Conduct root cause analysis using structured investigation techniques
• Monitor and track CAPA effectiveness and ensure timely completion
• Support QMS through metrics tracking, trend analysis, and risk identification
• Perform data analysis using Power BI dashboards and validate outputs
• Prepare reports and presentations for quality and compliance reviews
• Act as subject matter expert for GVP, GCP, and GMP related to safety data
• Collaborate with cross-functional teams and external vendors
• Support internal and external audits and inspection readiness activities
• Ensure data integrity across safety databases and documentation systems
• Drive continuous improvement initiatives in PV operations

Required Qualifications
• Strong understanding of pharmacovigilance quality systems and compliance
• Experience in root cause analysis, CAPA management, and deviation handling
• Knowledge of global PV regulations including FDA, EMA, and ICH guidelines
• Familiarity with PV systems such as Argus and Veeva Vault Safety
• Strong analytical, communication, and organizational skills

Educational Requirements:
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field

Experience and Skills:
• 3–5 years of core pharmacovigilance (case processing) experience
• 1–2 years of experience in quality management or QMS activities
• Experience in audit preparation and inspection readiness
• Knowledge of vendor management and PV operations workflows
• Strong expertise in documentation, SOP development, and process improvement
• Ability to perform data analysis and interpret quality metrics
• Experience with tools like Power BI is an added advantage

Salary Insights
• Estimated salary range: ₹12 LPA – ₹22 LPA (based on experience and expertise)

Company Overview
Alphanumeric Systems is a global provider of technology-enabled services, supporting leading pharmaceutical and healthcare organizations. The company specializes in delivering solutions across pharmacovigilance, regulatory, and IT domains, helping clients maintain compliance and operational excellence. With a strong global presence, it offers remote opportunities and exposure to large-scale international projects.

FAQs

• Is this a remote role?
Yes, this is a 100% remote role based in India.

• What is the primary focus of this role?
The role focuses on pharmacovigilance quality management, CAPA handling, and compliance.

• Is prior PV experience mandatory?
Yes, candidates must have core pharmacovigilance experience.

• What systems are commonly used in this role?
Systems like Argus and Veeva Vault Safety are commonly used.

• Does this role involve audits and inspections?
Yes, the role includes support for audit and inspection readiness.

Application Tips

• Highlight experience in CAPA, deviation handling, and root cause analysis
• Showcase knowledge of global PV regulations and compliance frameworks
• Mention hands-on experience with PV systems like Argus or Veeva
• Emphasize audit/inspection readiness and quality management exposure
• Demonstrate analytical skills and experience with data tools like Power BI