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
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 pharmaceutical sciences, medicine, pharmacy, or a related life sciences discipline, or equivalent relevant experience.
- A minimum of 3 years’ experience working in a Drug Safety or medical environment.
- 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.