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Clinical & PV Auditor

Recordati -
Milano, Lombardia

Candidati adesso

Dettagli della posizione

Tempo pieno

Qualifiche

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Outlook
Gestionale
Inglese
Google Cloud Platform
Microsoft Office
Competenze analitiche
Laurea triennale
Negoziazione
Audit interni

Descrizione completa della posizione

Clinical & PV Auditor

ID: 2163

Date of Posting: May 13, 2026

Business Area: Quality

Job Type: Direct Employee

On site / Remote / Hybrid: Hybrid

Hub Office: Milano, IT

Territory:

Full-Time or Part-Time: Full Time

Seniority: Mid-senior

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

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

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

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.

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