Senior Pharmacovigilance Auditor
2 weeks ago
Position Overview: The Senior Pharmacovigilance Auditor will spearhead and execute audits with an emphasis on Pharmacovigilance functions. This role encompasses various responsibilities aimed at enhancing the Pharmalearner Quality System, managing inspections, and overseeing regulatory intelligence activities.
Key Responsibilities:
- Pharmacovigilance Audits: Develop and uphold a global pharmacovigilance risk-based audit strategy.
- Lead, organize, and facilitate both internal and external GxP audits in accordance with the global audit framework and Pharmalearner's operational model.
- Monitor the progress of corrective and preventive actions in collaboration with internal and external stakeholders.
- Maintain an audit tracking system for findings and corrective actions.
- Support business operations as the Global Quality representative for software and infrastructure lifecycle activities.
- Drive continuous improvement initiatives within the Quality System by generating global metrics and learning from audits and inspections.
- Cover GxP-related functional areas, particularly focusing on GCP, GVP, GMP, and CSV.
- Collaborate with Functional Area Heads and Global Quality Leads to ensure effective quality management.
- Establish and maintain essential Quality Documentation and ensure compliance with applicable regulations.
- Identify and address process gaps within the Quality System, working closely with other functional areas.
- Manage deviations reported by functional areas and assist in their resolution.
- Develop and implement global compliance training procedures in partnership with other Pharmalearner entities.
Inspections:
- Assist in preparing for GxP inspections and respond to regulatory authorities.
- Track inspections, findings, and corrective actions effectively.
- Stay informed about relevant regulatory requirements and advancements in the regulatory landscape.
- Evaluate the impact of regulatory changes on the Pharmalearner Quality System.
- Facilitate information sharing and proactive actions to maintain compliance.
- Provide guidance and project liaison support to ensure quality standards are met.
Qualifications:
- A degree in a natural science or equivalent experience.
- Proven experience in Pharmacovigilance auditing, with auditor qualification preferred.
- Several years of relevant experience in clinical, industry, or regulatory environments, ideally with a focus on Quality Management.
- In-depth knowledge of regulations and guidance documents pertinent to Pharmacovigilance and Clinical Development.
- Experience in Monitoring, Quality Assurance, and Good Clinical Practices.
- Familiarity with inspection processes.
Competencies:
- Comprehensive understanding of pharmacovigilance requirements.
- Knowledge of audit and CAPA management processes.
- Proficiency in change management methodologies.
- Advanced skills in MS Office, particularly Excel and PowerPoint.
- Exceptional communication skills in English, both written and verbal.
- Strong problem-solving and analytical abilities.
This position offers a unique opportunity to contribute to the enhancement of quality systems within a dynamic organization.
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