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

- 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.

#J-18808-Ljbffr