Drug Safety Specialist

***Location: Romania Remote***

About the Company: At Arriello, we are Dedicated to challenging the status quo and providing customized solutions for our clients. Through Innovation, we collaborate with our clients, partners, and team members to proactively find new ways forward. We are Passionate about building meaningful relationships, always remaining empathetic and considerate in every interaction. Our commitment to being Inclusive drives us to foster a culture where equity, dignity, and learning from one another are central to our success.

Main Purpose of the Role:

Reporting directly to the Unit Lead for Safety Data Management, the Drug Safety Specialist plays a vital role in supporting case management activities and providing technical assistance across various units within the Pharmacovigilance (PV) department. The successful candidate will execute project-related tasks with precision, delegate effectively, and maintain a high standard of service quality.

Role Description:

• Execute project tasks specific to the unit, including but not limited to Global Individual Case Safety Report (ICSR) processing, Global Literature monitoring, Medicinal Product Management (XEVMPD), and Product documentation (SmPC,IB).
• Act as a Safety Data Coordinator for assigned projects, overseeing, coordinating, and delegating activities within the project team.
• Manage project-related PV contracts and escalate technical project issues as necessary.
• Support the improvement of processes within the assigned unit, ensuring smooth project execution and interdepartmental coordination.
• Provide administrative support to the department, including document management, project tracking, and communication with internal and external stakeholders.

Key Responsibilities:

• Work on projects and tasks assigned by management, ensuring excellence in project support and meeting deadlines.
• Act as a Process owner for assigned PV processes and provide training to team members as needed.
• Build effective working relationships with stakeholders and ensure compliance with processes and project deliverables.
• Participate in audits, inspections, and company marketing activities as required.
• Organize and maintain documents according to the company's document management system.

Minimum Qualifications:

• Degree in pharmaceutical sciences or related fields (advanced degree or significant relevant experience preferred).
• 3+ years of experience in medical or safety departments with a strong grasp of medical terminology.
• In-depth knowledge of Drug Safety regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.).
• Proven experience working with safety databases.
• Fluent in verbal and written English.
• A proactive, results-driven team player with strong organizational and time-management skills.

Offer:

• Flexible Work Options: Remote working flexibility to support your lifestyle.
• Generous Time Off Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
• Home Office Support: Get support to create a productive home office setup.
• Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.
• Dog-Friendly Offices: Bring your furry friend to work in our dog-friendly offices!

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 recruitment@arriello.com.