Pharmacovigilance Specialist (salary €40-45K)

Shionogi Europe; Roma; On-site; EUR 40,000 - 60,000; Full time

Job summary

Shionogi Europe is seeking a Pharmacovigilance Specialist in Rome, Italy, to enhance its global health initiatives. This position focuses on ensuring the compliance and quality of pharmacovigilance operations across Europe.

The ideal candidate will have relevant experience in pharmacovigilance and a scientific degree. Key responsibilities include aiding in regulatory compliance, supporting vendor oversight, and contributing to high standards in patient safety.

If you are driven by quality and collaboration in healthcare, we invite you to apply.

Qualifications

• Relevant experience in pharmacovigilance in the pharmaceutical industry.
• Understanding of pharmacovigilance regulations and GxP principles.
• Experience with PV systems and tracking tools is advantageous.

Responsibilities

• Support the maintenance of the Pharmacovigilance System Master File.
• Oversee PV vendors and review compliance deliverables.
• Conduct quality control for pharmacovigilance activities.

Skills

Pharmacovigilance experience

Knowledge of GVP regulations

Organisational skills

Fluency in English

Education

Degree in Pharmacy or Life Sciences

Tools

Microsoft Office Suite

Job description

Supporting Patient Safety and Pharmacovigilance Excellence

At Shionogi, we are committed to improving global health through innovation, collaboration and scientific excellence. As our European organisation continues to grow, we are strengthening our pharmacovigilance (PV) capabilities to ensure the highest standards of patient safety and regulatory compliance.

We are now seeking a Pharmacovigilance Specialist to support the delivery of operational PV activities across Europe and contribute to the continuous improvement of our pharmacovigilance system. This is an important role focused on ensuring compliance, accuracy and quality in all safety-related processes.

Why Join Shionogi?

Shionogi offers a purpose-driven, agile environment where individuals are empowered to make a meaningful impact. This role provides excellent exposure across the European organisation, collaboration with experienced PV professionals, and the opportunity to develop within a growing and dynamic function.

About the Role

As Pharmacovigilance Specialist, you will support the execution of pharmacovigilance activities, ensuring compliance with regulatory requirements and internal procedures, while contributing to maintaining high standards in patient safety and data quality.

Key responsibilities include:

• Supporting the maintenance and update of the Pharmacovigilance System Master File (PSMF)
• Supporting oversight of PV vendors, including review of deliverables and compliance checks
• Contributing to the preparation and quality control of Pharmacovigilance Agreements
• Performing quality control activities for PV trackers and compliance processes
• Supporting reconciliation activities with internal stakeholders and external vendors
• Contributing to the monitoring of PV compliance metrics and KPIs
• Contributing to the development and maintenance of PV SOPs and working instructions
• Supporting inspection and audit readiness activities, including documentation and follow-up actions
• Assisting with CAPA management, implementation and tracking
• Supporting in case processing, including data entry, quality review and follow-up in line with regulatory timeline
• activities and safety case follow-up
• Supporting the review of medical information enquiries and product quality complaints for safety relevance
• Supporting timely intake and triage of safety information through PV mailbox
• Providing general support to PV operational activities as needed

What Are We Looking For?

We are looking for a detail-oriented and proactive professional who is eager to develop within pharmacovigilance and contribute to a high-performing patient safety function.

You will bring:

• Relevant experience in pharmacovigilance within the pharmaceutical industry
• Basic knowledge of pharmacovigilance regulations (e.g. GVP) and GxP principles
• Familiarity with PV processes such as case processing, reconciliations and compliance monitoring
• Experience with PV systems and tracking tools is an advantage
• Strong organisational skills and attention to detail
• Ability to manage multiple tasks and prioritise effectively in a dynamic environment
• Degree in a scientific discipline (e.g. Pharmacy, Life Sciences or similar)
• Good communication and interpersonal skills
• Fluency in English, written and spoken
• Proficiency in Microsoft Office tools
• Proactive attitude and willingness to learn in a collaborative team environment

Join Us

Join Shionogi and contribute to safeguarding patient safety while developing your career within pharmacovigilance. If you are motivated by quality, collaboration and making a meaningful impact in healthcare, we would welcome your application.