Clinical & PV Auditor

Recordati; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company is seeking a Clinical & Pharmacovigilance Auditor to ensure compliance with regulatory requirements in clinical and pharmacovigilance activities. The role requires planning, conducting, and documenting audits, along with strong analytical and communication skills. Candidates should have a comprehensive background in Quality Assurance or Clinical Operations with at least five years of experience. This position offers full-time employment and requires approximately 50% travel to maintain inspection readiness.

Competenze

• Solid professional experience in the pharmaceutical or clinical research industry.
• Minimum five years experience in Quality Assurance or Clinical Operations.
• Proven experience conducting GCP and GVP audits.

Mansioni

• Plan, conduct, and document audits in Pharmacovigilance and Clinical Operations.
• Evaluate audit findings and prepare clear audit reports.
• Monitor corrective and preventive action plans.

Conoscenze

Analytical skills

Problem-solving skills

Communication skills

Conflict-resolution skills

Organizational skills

Formazione

University degree in Life Sciences

Postgraduate qualification in Clinical Research

Strumenti

Microsoft Office Suite

Veeva Vault Quality Suite

Descrizione del lavoro

Clinical & PV Auditor

Recordati, a global pharmaceutical company founded in the 1920s, is seeking a Clinical & Pharmacovigilance Auditor to strengthen its Quality Assurance function. The role ensures compliance of clinical development activities and the pharmacovigilance system with international and local regulatory requirements, internal procedures and Recordati quality standards.

Job Purpose

Independently plan, conduct, report and follow up on audits related to Clinical Operations and Pharmacovigilance activities. Verify compliance, contribute to continuous improvement of quality systems, patient safety and data integrity, and support inspection‑readiness projects.

Key Responsibilities

• Plan, prepare, conduct, document, and follow up on audits in Pharmacovigilance and Clinical Operations, on‑site and remotely.
• Conduct internal audits of Pharmacovigilance processes and systems, ensuring compliance with GVP modules and company procedures.
• Audit Pharmacovigilance vendors, distributors, licensees, licensors and business partners.
• Audit computerized systems supporting Pharmacovigilance and Clinical activities, validated by GAMP 5 principles and applicable legislation.
• Perform audits of company affiliates to assess compliance with global Pharmacovigilance and Clinical Quality Systems.

Clinical Auditing Responsibilities

• 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 (Pharmacy, Medicine, Biology, Biotechnology, Chemistry or related scientific disciplines).
• Advanced education or postgraduate qualification in Clinical Research, Pharmaceutical Sciences or Quality Assurance is an advantage.

Required Skills And Experience

• Solid professional experience in the pharmaceutical, biotechnology or clinical research industry.
• Minimum five 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.
• Strong analytical and problem‑solving skills, with the ability to assess complex regulatory and quality issues.
• Excellent written and verbal communication skills, with the ability to present findings and recommendations clearly.
• Strong conflict‑resolution and negotiation skills, applied professionally and constructively.
• Diplomatic approach and ability to interact effectively with internal and external stakeholders across 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 for Clinical Research and Pharmacovigilance.
• Strong understanding of GCP, GVP and relevant international and local regulations.
• Knowledge of computerized system validation principles and 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 Microsoft Word, Excel, PowerPoint, Teams and Outlook.
• Knowledge 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.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Accounting/Auditing and Finance

Industries

Pharmaceutical Manufacturing

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly and be bold, we invite you to apply today.