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, 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.

  
  

Key Relationships

• Internal: Quality and PV teams, local affiliate staff, cross-functional departments.

  
  

• External: Competent authorities, Galderma Global partners, third‑party affiliates.

  
  

Qualifications and Skills

• Bachelor of Science in Pharmacy with a valid Pharmacist License required

  
  

• Minimum 2 years of experience in the bio/pharma industry, preferably in Regulatory Affairs or Quality Assurance and Pharmacovigilance.

  
  

• Experience with cosmetics, prescription, OTC, and medical device products.

  
  

• Knowledge of local regulatory guidelines and compliance requirements in Saudi Arabia.

  
  

Our people make a difference

At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.