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 creating and maintaining vendor organization records related to PV activities within the Quality Management System (QMS). The role also supports ensuring adverse event (AE) reporting requirements are clearly defined within contracts and agreements. In few words, this role is primarily vendor oversight on the submission of AEs to the FDA, EMA. When applicable, the role assists in internal and external audits of PV vendors, as well as reporting and tracking CAPAs.
Key Responsibilities:
- 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.
- Serve as QA SME for GVP and GCP as they relate to safety data.
- 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.
Education 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.
Job Related Experience:
- 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.
- Strong communication, problem‑solving, and organizational skills.
- 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.