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Pharmacovigilance Quality Assurance Principal Scientist
Location
India
Posted
136 days ago
Salary
0
Seniority
Lead
Job Description
Pharmacovigilance Quality Assurance Principal Scientist
Alphanumeric Systems
• Support audits/inspections and contribute to CAPA development and resolution • Manage PV deviations and CAPAs, including investigation, documentation, and timely closure • Oversee the QMS with metrics, trend analysis, and risk indicators • Provide PV vendor oversight, including risk‑based auditing and monitoring of third‑party performance • Oversee Global Case Management PV vendor activities related to ICSR processing • Provide QA oversight for end‑to‑end PV activities: case processing, safety surveillance, risk management, and signal detection • Develop and implement global PV QA strategies and risk‑based audit programs aligned with FDA, EMA, MHRA, ICH, and other regulatory requirements • Author, review, and maintain PV‑related SOPs, WIs, and quality documentation • Collaborate cross‑functionally to ensure high‑quality, compliant documentation and processes • Conduct root cause analyses and author deviations, investigations, and CAPAs • Support trending analyses with third‑party vendors and internal stakeholders • Track metrics and prepare presentations for client reporting • Recommend and implement process improvements to prevent repeat issues • Escalate PV operations issues to appropriate management • Contribute to global PV operations process improvements and innovation initiatives • Partner with PV service providers to design and monitor quality‑driven processes, supporting activities such as audits and performance reviews • Support inspection and audit readiness, including documentation preparation and SME participation • Ensure data integrity across safety systems, documentation repositories, and workflow platforms • Manage workload effectively and coordinate cross‑functional deliverables using project management skills
Job Requirements
- Degree in life sciences or medical related field or previous experience equating to educational requirements
- An advanced degree in strategy, innovation or leadership is an advantage
- Experience in operational risk assessment, quality issue management, CAPA development, and audit preparation
- Knowledge of PV vendor and contract management
- Familiarity with global PV regulations (FDA, EMA, ICH)
- Experience auditing PV vendors, CROs, or specialty pharmacies, including report writing and CAPA tracking
- Experience in clinical trial and post‑marketing PV
- Experience with SOP development, process review, and PV/clinical/regulatory documentation
- Experience with CAPA, RCA, and structured follow‑up plans
- Ability to map complex PV processes and manage document updates through quality systems
- Experience with PV systems such as Argus, ArisGlobal, or Veeva Vault Safety
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
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