Pharmacovigilance Quality Assurance 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.