PV Operations QMS Support Principal Scientist - 100% remote from India

Pharmacovigilance Principal Scientist (100% remote) Overview: Alphanumeric is seeking a Pharmacovigilance Quality Assurance Principal Scientist (100% remote) based in India for fixed term employment. This project is for one of the biggest pharmaceutical brands in the world. Job Purpose: The primary purpose of this role is to support Pharmacovigilance Management Systems for PV Operations. Responsibilities include end-to-end management of issues/deviations and findings related to PV activities within the Quality Management System (QMS); monitor and track issues and corrective and preventative action plans (CAPAs) to ensure timely completion and delivery of high-quality root cause analyses (RCA) and CAPAs. When applicable, the role assists in internal and external audits of PV vendors. Key Responsibilities: • Manage PV non‑conformances and CAPAs, including conducting investigations (using recognised techniques), documenting outcomes, and ensuring timely closure. • Support the QMS with metrics, trend analysis, and risk indicators. • Perform metric calculations using Power BI dashboards, validating outputs through agreed filters and late‑case reconciliation, and prepare presentations where required • Serve as QA SME for GVP, GCP, GMP as they relate to safety data. • Collaborate cross‑functionally to ensure high‑quality, compliant documentation and processes, while effectively managing workload and coordinating key deliverables using strong project‑management skills. • Support trending analyses with third‑party vendors and internal stakeholders. . • Escalate PV operations issues to appropriate PV management. • Contribute to global PV operations process improvements to reduce repeat issues • Ensure data integrity across safety systems, documentation repositories, and workflow platforms. Education Requirements: • A minimum of a bachelor’s degree in a life science, nursing, or a related field (e.g., pharmacology, biochemistry) is required or previous experience equating to educational requirements. • Candidates should have at least 3-5 years of core PV (case processing) experience, along with a minimum of 1–2 years of experience in quality management, including activities such as performing root cause analysis and related quality/compliance oversight. Job Related Experience: to include but not limited to the following: • Extensive experience in operational risk assessment, quality issue management, root cause analysis, corrective and preventative action (CAPA) development and tracking and audit/inspection preparation. • Knowledge of PV vendor management. • Familiarity with global PV regulations (FDA, EMA, ICH). • Experience in clinical trial and post‑marketing PV. • Strong communication, problem‑solving, and organizational skills. • Experience with SOP development, process review, and PV/clinical/regulatory documentation. • Good documentation practices and stakeholder management skills. • Ability to map complex PV processes and manage document updates through quality systems. • Experience with PV systems specifically Argus, and Veeva Vault Safety.