PV & Quality Officer, QPPV KSA

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.**Job Title:** PV & Quality Officer, QQPV**Localisation :** Riyadh**Mission of the Role**You will ensure the highest standards of Quality Assurance and Pharmacovigilance in Saudi Arabia, maintain regulatory compliance, and promote a strong culture of safety and quality within the organization.The QPPV (Qualified Person for Pharmacovigilance)/Quality Officer coordinates and supports Quality Assurance and Pharmacovigilance activities at Galderma Arabia, ensuring alignment with local regulations and internal policies.This role uniquely combines Quality Assurance and Pharmacovigilance responsibilities, acting as a key link between local operations and global standards while ensuring compliance with local regulations.**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, Pharmacovigila