Location: Remote (Global) – EU, US, Asia, Africa
Employment Type: Full-Time (100% FTE)
Department: Pharmacovigilance / Drug Safety / Quality & Compliance
Reports To: Manager/Director, PV Quality & Compliance

Role Overview:

The Pharmacovigilance (PV) Quality Specialist supports the integrity and compliance of global pharmacovigilance operations. This role is responsible for managing Corrective and Preventive Actions (CAPAs), conducting Root Cause Analyses (RCAs), supporting audits and inspections, and driving continuous improvement across PV systems.

This fully remote position is ideal for a detail-oriented quality professional with experience in PV compliance, CAPA systems, and regulatory expectations (e.g., GVP, FDA, EMA).

Key Responsibilities:

Manage Corrective and Preventive Actions (CAPAs) related to pharmacovigilance findings, deviations, and quality events, ensuring timely closure and documentation.
Conduct Root Cause Analyses (RCAs) using structured methodologies (e.g., 5 Whys, Fishbone) to identify and address quality and compliance issues.
Prepare for and support internal/external audits and inspections, including health authority inspections (e.g., EMA, MHRA, FDA).
Implement quality system improvements, including SOP updates, training enhancements, and process optimizations based on CAPA outcomes or audit results.
Track compliance metrics (e.g., CAPA cycle time, deviation trends, audit KPIs) and contribute to management reviews and risk assessments.
Collaborate cross-functionally with PV Operations, Regulatory Affairs, and Quality Assurance to ensure consistent quality practices and regulatory alignment.
Maintain inspection readiness across PV functions and support periodic quality and compliance reviews.
Monitor global PV regulatory changes and apply them to internal procedures and documentation.

Required Qualifications:

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
Minimum of 3 years’ experience in pharmacovigilance, with at least 1–2 years in a PV quality, compliance, or CAPA-focused role.
Solid knowledge of Good Pharmacovigilance Practice (GVP) guidelines and global regulatory frameworks.
Demonstrated experience with CAPA systems, RCA tools, and compliance monitoring.
Familiarity with PV systems and QMS tools (e.g., Veeva Vault, TrackWise, Argus).
Excellent analytical, communication, and documentation skills.
Ability to work in a remote, global team environment and adapt to shifting priorities.

Preferred Qualifications:

Experience supporting health authority inspections (e.g., FDA, EMA).
Quality system certification (e.g., RQA, ISO 9001 Lead Auditor) is advantageous.
Background working with outsourced or vendor-supported PV models.
Familiarity with inspection readiness activities or Quality Management Reviews (QMRs).

Work Environment:

Fully remote and global-facing.
Flexible work hours to accommodate audit/inspection timelines.
Collaborates closely with internal and external PV and QA stakeholders.