Clinical & PV Auditor

Location: Via Milano

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.
Profi…