PV Operations QMS Support Principal Scientist
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Job Description
Pharmacovigilance Quality Assurance Principal Scientist supporting QMS for global pharmaceutical brand. Manage non-conformances, CAPAs, and collaborate cross-functionally for compliance.
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.
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.
- At least 3-5 years of core PV (case processing) experience.
- A minimum of 1–2 years of experience in quality management, including activities such as performing root cause analysis and related quality/compliance oversight.
- 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.
Benefits:
- 100% remote from India
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