Key Facts

Remote From:

Full time

Expert & Leadership (>10 years)

English

Hard Skills

Pharmacovigilance Safety Management Systems Project Management Active Safety Drug Administration Pharmaceutical Product Management Legal Electronic Data Exchange Standard Daily Production Reports Continuous Improvement Process Pharmaceutical Security +12 more

Other Skills

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Communication
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Time Management
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Teamwork
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Organizational Skills
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Detail Oriented
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Relationship Building

Roles & Responsibilities

Bachelor's degree in medicine, pharmacy, dentistry, or veterinary medicine
Minimum 3 years' experience in pharmacovigilance
Strong knowledge of drug safety regulations and guidelines (ICH, GVP, GCP, CIOMS)
Significant experience working with a safety database

Requirements:

Manage local and global Drug Safety activities including local literature monitoring, LPPV/LSO management, monthly reporting, and reconciliation.
Deliver end-to-end Drug Safety activities across projects, including ICSR processing, literature monitoring, and compliance monitoring.
Process safety reports (AEs, SAEs, SUSARs) from receipt to submission; support reconciliation of safety data with clinical databases and monitor local reporting requirements.
Maintain safety documentation (SmPCs, IBs, Safety Management Plans) and manage safety-related contracts/agreements; contribute to signal management and training.

Job description

This is a remote position.

At Arriello, we provide Pharmacovigilance, Quality & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies, helping them meet regulatory requirements and protect patient safety.

We are a growing business with a collaborative culture focused on high‑quality delivery, continuous improvement, and giving people the space to do their best work.

Our values guide how we work:

Inclusive – We value fairness, respect, and learning from one another
Dedicated – We deliver practical, client‑focused solutions
Innovative – We work together to find better ways forward
Passionate – We build strong relationships and care about the quality of what we do

The Opportunity

We are seeking an experienced Pharmacovigilance Specialist specialised in Local PV to join our Local Drug Safety team in Croatia . This role plays a key part in the delivery of high-quality Drug Safety services across a diverse portfolio of projects, working both within the department and cross-functionally.

You will be responsible for executing technical Drug Safety activities, supporting process improvements, and ensuring projects are delivered in line with regulatory requirements, client expectations, and internal quality standards.

What You Will Do

Manage local and global Drug Safety activities such as local literature monitoring, LPPV or LSO management, monthly reporting, and reconciliation activities.
Deliver end-to-end Drug Safety activities across assigned projects, including ICSR processing, literature monitoring, and compliance monitoring.
Process safety reports from all sources, including receipt, coding, assessment, and submission of AEs, SAEs, and SUSARs.
Support reconciliation of safety data with clinical databases and monitor local country reporting requirements.
Perform Global Literature monitoring and Medicinal Product Management activities, including XEVMPD.
Support the development and maintenance of safety documentation, including SmPCs, IBs, Safety Management Plans, and clinical safety documents.
Manage project-related Drug Safety contracts, including service agreements and safety data exchange agreements.
Support Signal Management and Benefit Risk Management activities.
Deliver and support Global Drug Safety training for project teams and internal stakeholders.
Act as Process Owner for assigned Drug Safety processes and contribute to continuous process improvement.
Escalate technical or delivery issues to the Project Manager or Line Manager as required.
Maintain accurate documentation, tracking, and reporting in line with company systems and procedures.
Collaborate closely with internal teams and external stakeholders, including Clients, Competent Authorities, and Vendors.
Participate in audits, inspections, client meetings, and company marketing activities as required.

Requirements

Bachelor’s degree in medicine,pharmacy,dentistry or veterinary medicine.
A minimum of 3 years’ experience working in a pharmacovigilance.
Strong knowledge of Drug Safety regulations, processes, and guidelines, including ICH, GVP, GCP, and CIOMS.
Significant experience working with a safety database.
Excellent organisational skills with the ability to manage multiple priorities and meet deadlines.
Strong communication skills and the ability to build effective working relationships
A collaborative, proactive approach with a strong focus on quality and continuous improvement.
Fluent English and Croatian, written and spoken.