PV & Quality Officer, QPPV Galderma

Job Title: PV & Quality Officer, QQPV

Responsibilities

Quality Management System (QMS) Oversight

• Implement and maintain the Affiliate Quality Management System in compliance with corporate policies and regulatory requirements.
• Update SOPs and conduct internal audits to reflect current practices and regulations.

Pharmacovigilance (PV) System Oversight

• Serve as the Qualified Person for Pharmacovigilance (QPPV) in Saudi Arabia and act as the primary contact for the SFDA.
• Manage and oversee the PV system, adverse event reporting, and SDEAs with third parties.
• Implement and maintain the Affiliate PV System in line with corporate and regulatory requirements.
• Establish and maintain the local vigilance system and manage safety information according to global SOPs, third party agreements, and local regulations.
• Maintain the local Pharmacovigilance Sub-System Master File (PSSF) as required.
• Develop and maintain local SOPs and supporting documents.
• Stay updated on local safety legislation for medicinal products, cosmetics, and medical devices, and inform Global PV of any changes.
• Nominate a back-up LSO and ensure 24/7 vigilance coverage.
• Provide the EU-QPPV with 24-hour contact details and communicate any updates.
• Maintain a local vigilance email inbox for safety information exchange.
• Ensure procedures are in place for receiving, tracking, quality controlling, and reconciling Adverse Events (AEs).
• Keep local vigilance records updated according to Galderma procedures and local requirements.
• Monitor the safety of Galderma products and inform Global PV of any changes affecting the benefit risk profile.
• Inform Global PV of all third party agreements and vigilance qualification/audit questionnaires signed locally.
• Notify Global PV of non-interventional studies and interventional clinical trials involving marketed products in Saudi Arabia.
• Participate in periodic Global and Regional PV meetings.
• Ensure management and submission of PSURs/PBRERs according to local regulations.
• Manage medical queries and safety-related complaints.
• Oversee local post-marketing studies, including market research and surveys.
• Ensure appropriate local trend/signal detection and inform Global PV of any changes impacting the benefit risk profile.

Compliance Monitoring

• Monitor adherence to GMP, GDP, and PV standards.
• Ensure compliance with quality and safety agreements with third-party affiliates and maintain product sample integrity.

Risk Management

• Conduct risk assessments related to product safety and quality, implement mitigation strategies, and ensure compliance with local regulatory requirements.
• Monitor and evaluate the effectiveness of risk management activities.

Training and Development

• Develop and deliver training programs on Quality Assurance, Pharmacovigilance, regulatory requirements, and best practices.
• Ensure all personnel are adequately trained and maintain training records.

Quality Incident and Safety Data Management

• Oversee investigations of quality incidents, deviations, and non-conformances, and implement CAPA.
• Analyze and report Quality and Vigilance KPIs, and maintain strong relationships with regulatory authorities and internal stakeholders.

Documentation and Reporting

• Ensure proper documentation practices and manage quality and safety records.
• Prepare and submit required quality and safety reports to corporate and regulatory authorities.

Collaboration with Global Teams

• Work closely with the global PV team to ensure alignment on safety reporting processes and standards.
• Liaise with regulatory authorities on PV matters and respond to inquiries.

Cross-Functional Collaboration

• Build strong relationships with regulatory affairs, clinical operations, and commercial teams.
• Represent Quality Assurance and Pharmacovigilance in cross-functional meetings and initiatives.

GxP Audits and Inspections

• Manage GxP audits and inspections, ensuring readiness and compliance, and support additional QA and PV tasks as needed.

Continuous Improvement

• Promote a culture of continuous improvement and encourage proactive identification and resolution of quality and safety issues.
• Lead initiatives to enhance quality and safety processes in alignment with global standards.

Reference Role Tasks

• Maintain the local Quality Management System and Pharmacovigilance System.
• Monitor compliance status and implement corrective actions when necessary.
• Coordinate with internal and external stakeholders to ensure effective communication and collaboration.