This is a remote position.
About Arriello:
At Arriello, we provide a full range of Pharmacovigilance, Quality & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies. With a team of experienced professionals, we support our clients in meeting their regulatory obligations, maintaining product quality and patient safety, and navigating complex global compliance landscapes.
As a growing business with a dynamic culture, we are committed to high-quality delivery, continuous improvement, and creating an environment where people can thrive.
At Arriello, our values define how we work — and who we are:
Inclusive - We value equity, inclusion and dignity for all, recognising that we learn from each other every day.
Dedicated - We challenge the status quo to deliver pragmatic, tailored solutions for our clients.
Innovative - We collaborate closely—with our clients, colleagues and partners—to proactively find better ways forward.
Passionate - We build strong relationships based on empathy, respect and a genuine commitment to delivering quality in everything we do.
Arriello is a specialist global consultancy supporting life sciences organisations across Pharmacovigilance, Regulatory Affairs, and Quality and Compliance. We work in close partnership with our clients, delivering high-quality, pragmatic solutions across the product lifecycle.
Our culture is built on being Inclusive, Dedicated, Innovative, and Passionate. We value expertise, accountability, and collaboration, and we support our people to grow through meaningful work and continuous development
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.
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.
Arriello is an Equal Opportunity Employer. We are committed to creating a diverse, inclusive, and respectful workplace where all individuals are valued and treated with dignity. We encourage applicants from all backgrounds, including but not limited to race, colour, religion, gender, gender identity, sexual orientation, age, disability, national origin, or any other characteristic protected by law.
In line with our commitment, we provide reasonable accommodations to applicants with disabilities throughout the hiring process. If you require any accommodation, please contact us at [email protected] .