Job Details – Pharmacovigilance QA Role
- Position: PV Operations QMS Support – Principal Scientist
- Location: India (100% Work From Home)
- Experience Required:
- 3–5 years in Pharmacovigilance Operations
- 1–2 years in Quality Assurance / QMS
- Job Type: Full-Time (Fixed Term)
- Functional Area: Drug Safety, Pharmacovigilance, Quality & Compliance
Pharmacovigilance jobs
Pharmacovigilance jobs: Are you an experienced Pharmacovigilance (PV) professional looking to transition into Quality Assurance (QA), QMS, and compliance leadership roles?
A premium global opportunity is now open with Alphanumeric Systems for the position of Pharmacovigilance QA Principal Scientist — a fully remote job in India offering exposure to international regulatory frameworks, audits, and high-level PV operations.
This role is ideal for candidates with a strong foundation in ICSR case processing, CAPA management, Root Cause Analysis (RCA), and pharmacovigilance compliance systems.
About the Company – Alphanumeric Systems
Alphanumeric Systems is a globally recognized organization providing services to leading pharmaceutical and life sciences companies. Known for its excellence in drug safety, IT solutions, and regulatory compliance, the company offers professionals the opportunity to work on cutting-edge pharmacovigilance systems and global quality frameworks.
Detailed Roles & Responsibilities
In this Pharmacovigilance QA job, you will be responsible for maintaining and improving quality systems across global PV operations:
PV Quality Management & Compliance
- Handle non-conformances, deviations, and quality events within PV systems
- Lead CAPA (Corrective and Preventive Action) processes from initiation to closure
- Ensure compliance with global pharmacovigilance guidelines (ICH-GVP, FDA, EMA)
Root Cause Analysis (RCA) & Risk Management
- Perform in-depth RCA investigations using structured tools (5 Whys, Fishbone, etc.)
- Identify systemic gaps and process risks
- Develop risk mitigation strategies and preventive controls
Data Analysis & Reporting
- Perform trend analysis and signal identification support
- Generate quality metrics, dashboards, and reports using Power BI
- Monitor KPIs related to case processing, compliance timelines, and audit findings
Audit & Inspection Readiness
- Support regulatory inspections and internal audits
- Participate in vendor audits and compliance assessments
- Ensure readiness for global regulatory bodies (FDA, EMA, MHRA)
Systems & Tools Management
- Ensure data accuracy in:
- Argus Safety Database
- Veeva Vault Safety
- QMS platforms
- Maintain data integrity, consistency, and regulatory documentation standards
Cross-Functional Collaboration
- Work with clinical, regulatory, and safety teams
- Contribute to SOP development, revisions, and training
- Drive continuous process improvement initiatives
Eligibility Criteria
Educational Qualification
- B.Pharm / M.Pharm / Pharm.D/BDS
- MSc / BSc (Life Sciences, Pharmacology, Nursing)
Experience
- 3–5 years in Pharmacovigilance Operations (ICSR, case processing, aggregate reports)
- 1–2 years in QMS / QA / CAPA / compliance roles
Key Skills (High-Ranking SEO & ATS Keywords)
To rank higher and get shortlisted, your profile should include:
- Pharmacovigilance (PV) Operations
- ICSR Processing & Case Management
- CAPA Management & Effectiveness Checks
- Root Cause Analysis (RCA)
- PV Quality Management System (QMS)
- Global Regulations (ICH-GVP, FDA, EMA)
- Argus Safety / Veeva Vault Safety
- Audit & Inspection Readiness
- Risk Assessment & Compliance Monitoring
- SOP Writing & Documentation
- Data Integrity & Regulatory Compliance
- Stakeholder & Vendor Management
Salary & Compensation (India Market Insight)
- Expected Salary Range: ₹12 LPA – ₹22 LPA
- Depends on:
- PV QA experience
- QMS expertise
- Exposure to global audits
- Technical tool proficiency
Another opening:
Why You Should Apply for This Role
Career Growth
- Move from PV Operations → PV QA / Compliance Leadership
- Gain expertise in high-demand domains like CAPA, RCA, QMS
Global Exposure
- Work with international pharmaceutical clients
- Handle global audits and regulatory frameworks
Remote Flexibility
- 100% Work From Home across India
- Better work-life balance
High Demand Skillset
- Pharmacovigilance QA professionals are among the most in-demand roles in drug safety
Ideal Candidate Profile
This opportunity is perfect for:
- PV professionals aiming for career transition into QA/QMS
- Candidates with hands-on CAPA and deviation management experience
- Professionals preparing for Pharmacovigilance QA interviews
- Individuals with strong knowledge of global regulatory guidelines
How to Apply
👉 Visit the official careers page of Alphanumeric Systems or apply via trusted job portals. or Click on this: CLICK HERE
Tip: Customize your resume with keywords like CAPA, RCA, PV QMS, Argus, and audit readiness to increase your chances of selection.
