Clinical Safety Specialist

Advancing patient safety. Building trusted partnerships. Growing careers.

At Arriello, we help pharmaceutical and life sciences organisations navigate complex regulatory requirements while keeping patient safety at the centre of everything we do.

Through our expertise in Pharmacovigilance, Quality & Compliance, and Regulatory Affairs, we support clients across the globe in delivering safe and effective medicines to patients. As our business continues to grow, we are looking for talented professionals who are passionate about quality, collaboration, and making a meaningful impact.

We are proud of our supportive and inclusive culture, where people are encouraged to share ideas, develop their expertise, and contribute to continuous improvement. If you are looking for an opportunity to apply your skills in a dynamic international environment while continuing to build your career, we would love to hear from you.

Our Values

Our values shape how we work every day:

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.

About the Role

As a Clinical Safety Specialist, you will play an important role in helping our clients maintain the highest standards of patient safety throughout the product lifecycle. This is an excellent opportunity for an experienced pharmacovigilance professional who enjoys combining technical expertise, project coordination, stakeholder collaboration, and continuous improvement.

Working within our Global Drug Safety team, you will take ownership of key safety activities, support complex client projects, and act as a trusted partner to both internal and external stakeholders. You will have the opportunity to contribute across a wide range of pharmacovigilance and drug safety activities while helping to shape processes, mentor colleagues, and drive quality across projects.

If you are motivated by making a meaningful contribution to patient safety and are looking for a role where your expertise will have real impact, we would love to hear from you.

What You Will Be Doing

In this role, you will:

• Deliver technical pharmacovigilance and drug safety activities across client projects.
  
• Support the successful delivery of project objectives, ensuring quality, compliance, and adherence to timelines.
  
• Act as a technical lead for assigned projects, providing day-to-day guidance and oversight.
  
• Collaborate with clients, vendors, and cross-functional teams to ensure service excellence.
  
• Identify opportunities for process improvements and contribute to operational excellence initiatives.
  
• Support project scoping activities and proposal development where required.
  
• Escalate technical or compliance-related issues appropriately and proactively.
  
• Contribute to maintaining a high-quality, inspection-ready environment.
  

Key Responsibilities

Technical Drug Safety Activities

• Perform and oversee end-to-end Global Drug Safety activities.
  
• Conduct reconciliations and support oversight activities.
  
• Develop and maintain Safety Management Plans and Project Management Plans.
  
• Perform literature monitoring activities.
  
• Support Signal Management and Benefit-Risk management activities.
  
• Manage XEVMPD medicinal product maintenance activities.
  
• Provide Regulatory Intelligence support.
  
• Prepare safety-related reports, documentation, and project deliverables.
  
• Support risk management, study-related, and product safety documentation activities.
  

Project Leadership & Coordination

• Act as technical lead for assigned projects.
  
• Coordinate project deliverables, timelines, priorities, and day-to-day operational activities.
  
• Support efficient project execution and client satisfaction.
  
• Ensure deliverables meet contractual obligations and client expectations.
  
• Escalate project risks and technical issues to the Project Manager or relevant leadership teams when required.
  
• Organise and participate in project and client meetings.
  

Quality, Compliance & Process Ownership

• Support audit readiness activities and inspection preparation.
  
• Manage audit findings, CAPAs, and continuous improvement actions.
  
• Complete and contribute to RFI and QAQ questionnaires.
  
• Act as process owner for assigned Global Drug Safety processes.
  
• Ensure compliance with internal procedures, industry regulations, and client requirements.
  
• Drive quality improvements through feedback, lessons learned, and best practice sharing.
  

Collaboration & Team Development

• Work closely with clients, vendors, and internal teams including Global Drug Safety, Quality & Compliance, Regulatory Affairs, Commercial, and other stakeholders.
  
• Build strong and effective working relationships across international teams.
  
• Mentor, support, and train junior team members.
  
• Share technical expertise and contribute to knowledge development across the wider team.
  
• Participate in internal and external training initiatives and business activities as required.
  

Essential Skills & Experience

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Medicine, or a related discipline.
  
• Minimum 3 years of experience within pharmacovigilance, drug safety, or a related safety environment.
  
• Strong knowledge of Drug Safety regulations, processes, and industry guidelines including ICH, GVP, GCP, and CIOMS.
  
• Experience working with safety databases.
  
• Experience managing multiple priorities while maintaining a high standard of quality and compliance.
  
• Strong project coordination and stakeholder management skills.
  
• Experience working cross-functionally with internal and external stakeholders.
  
• Excellent communication and organisational skills.
  
• Fluent written and spoken English.
  
• A collaborative approach and a passion for continuous improvement.
  

Nice to Have

• Experience with Veeva Vault Safety.
  
• Experience across both clinical trial and post-marketing environments.
  
• Experience supporting client-facing projects in a consultancy, CRO, or service-based environment.
  
• Experience contributing to audits, inspections, and CAPA management.
  

• Flexible working arrangements.
  
• Opportunities for professional development and career progression.
  
• Exposure to international clients and diverse project portfolios.
  
• A collaborative and supportive culture built on knowledge-sharing and teamwork.
  
• The opportunity to work alongside leading pharmacovigilance and regulatory experts.
  
• Meaningful work that directly contributes to patient safety and public health.
  
• Recognition for your expertise, contributions, and achievements.
  

Equal Opportunities

Arriello is committed to creating a diverse, inclusive, and respectful workplace where everyone is valued and treated with dignity. We welcome applications from all backgrounds and are dedicated to providing reasonable accommodations throughout the recruitment process where required.