Job Purpose
We are looking for a Clinical and Pharmacovigilance Auditor to play a key role within the Quality Assurance function, ensuring that the Company's clinical development activities and pharmacovigilance system are compliant with applicable international and local regulatory requirements, internal procedures, and Recordati quality standards.
The purpose of this role is to independently plan, conduct, report, and follow up on audits related to Clinical Operations and Pharmacovigilance activities, to verify the compliance of the auditee activities to agreements, regulations, guidelines, contributing to the continuous improvement of quality systems, patient safety, and data integrity across the organization and its external partners.
The Auditor operates within a global, cross-functional environment and works closely with internal departments (Clinical Operations, Pharmacovigilance, Regulatory Affairs, IT, Quality Assurance) as well as external stakeholders such as CROs, vendors, affiliates, distributors, licensees, licensors, and clinical sites, laboratories.
This position is embedded in the Quality Assurance team and supports both ongoing and inspection-readiness activities by identifying compliance risks, assessing system robustness, and promoting a strong quality culture. The role requires a high level of independence, professional judgment, and the ability to interact diplomatically with stakeholders at all organizational levels.
Key Responsibilities
• Plan, prepare, conduct, document, and follow up on audits in the areas of Pharmacovigilance and Clinical Operations, both on-site and remotely
• Perform internal audits of Pharmacovigilance processes and systems, including compliance with GVP modules and company procedures
• Conduct audits of Pharmacovigilance vendors, distributors, licensees, licensors, and business partners
• Audit computerized systems supporting Pharmacovigilance and Clinical activities, including validated systems, in accordance with GAMP 5 principles and applicable legislation
• Perform audits of company affiliates to assess compliance with global Pharmacovigilance and Clinical Quality Systems
Clinical Auditing Resposibilities:
• Conduct qualification audits of CROs responsible for clinical trial conduct
• Perform study-specific audits (Phase I–IV, bioequivalence studies, Post-Authorization studies)
• Audit clinical processes, procedural systems, and quality management frameworks supporting clinical trials
• Audit electronic Case Report Forms (eCRF), Trial Master File (TMF), Clinical Study Reports (CSR), and associated documentation
• Conduct on-site audits at clinical investigator sites where studies are performed
• Perform audits of clinical vendors and service providers
Compliance Activities:
• Evaluate audit findings, assess risk and criticality, and prepare clear, accurate, and timely audit reports
• Monitor and assess corrective and preventive action (CAPA) plans and their effectiveness in Veeva QMS
• Support inspection readiness activities and contribute to regulatory inspection support when required
• Contribute to continuous improvement initiatives within the Quality Assurance system
Required Education
• University degree in Life Sciences (e.g., Pharmacy, Medicine, Biology, Biotechnology, Chemistry, or related scientific disciplines)
• Advanced education or postgraduate qualification in Clinical Research, Pharmaceutical Sciences, or Quality Assurance is considered an advantage
Required Skills and Experience
• Solid professional experience in the pharmaceutical, biotechnology, or clinical research industry
• Minimum of 5 years of experience in Quality Assurance, Clinical Operations, Pharmacovigilance, or auditing activities within a regulated GxP environment
• Proven experience in conducting GCP and GVP audits, including vendor and system audits, is strongly preferred
• Strong analytical and problem-solving skills, with the ability to assess complex regulatory and quality issues
• Excellent communication skills, both written and verbal, with the ability to clearly present findings and recommendations
• Strong conflict-resolution and negotiation skills, applied in a professional and constructive manner
• Diplomatic approach and ability to interact effectively with internal and external stakeholders across different cultures and organizational levels
• Ability to work independently and manage audits from planning through closure
• Experience working in international and multicultural environments
• Strong organizational skills and ability to manage multiple priorities under tight timelines
• High level of integrity, discretion, and respect for confidentiality
Technical Competencies
• In-depth knowledge of GxP standards and regulatory requirements applicable to Clinical Research and Pharmacovigilance
• Strong understanding of GCP, GVP, and relevant international and local regulations
• Knowledge of computerized system validation principles and applicable legislation (e.g., GAMP 5)
• High level of accuracy, precision, and attention to detail in audit execution and documentation
• Ability to critically review complex technical and regulatory documentation
• Proficiency in the use of Microsoft Word, Excel, PowerPoint, Teams, and Outlook
• Knowledge in use of Veeva Vault Quality Suite or experience with electronic document management systems (eDMS) and other quality or clinical systems
• Ability to prepare high-quality audit reports and risk-based assessments
Required Behaviours and Competencies
• Strong sense of responsibility and ownership of assigned activities
• High ethical standards and strict adherence to rules, procedures, timelines, and confidentiality requirements
• Flexible and adaptable mindset, with the ability to respond effectively to changing priorities
• Initiative and strong self-motivation, with a proactive approach to problem identification and resolution
• Positive attitude, enthusiasm, and commitment to quality and continuous improvement
• Ability to work effectively both independently and as part of a team
• Professional, respectful, and customer-oriented approach when interacting with internal and external stakeholders
• Resilience and ability to perform under pressure in a regulated and deadline-driven environment
Required Languages
• English: Fluent (spoken and written) – mandatory
• Ability to prepare and review audit documentation and conduct audits entirely in English
• Knowledge of additional languages is considered an advantage
Travel required in %
Approximately 50% travel requirement