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Drug Safety Specialist

Role overview

Qualifications

  • 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

Responsibilities

  • Support the delivery of Clinical Safety and Pharmacovigilance services across a range of client projects
  • Perform Clinical Safety and Global Drug Safety activities in line with regulatory requirements, company procedures, and client expectations
  • Contribute to the preparation and maintenance of safety-related documentation and project deliverables
  • Collaborate effectively with clients, vendors, and internal stakeholders across Quality Compliance, Regulatory Affairs, Commercial, and other teams

Key facts

Hard skills

Other skills

  • Communication
  • Collaboration
  • Organizational Skills

About the company

Arriello logo

Arriello

Contract Research Organizations (CRO)

Arriello is a leading life sciences consultancy, offering expert guidance in regulatory affairs, pharmacovigilance and quality compliance. Our global services span the product lifecycle from clinical to post-submission regulatory affairs, pharmacovigilance, and quality & compliance. Headquartered in Ireland and with operations across Europe, we provide services and solutions globally. With decades of experience, ISO:9001 certification, and a friendly, diverse team, we‘ve been a trusted partner to the life sciences industry, primarily with pharmaceutical and biotech companies since 2008.

Company details

IndustryContract Research Organizations (CRO)
Company size51 - 200

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Job description

This is a remote position.

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

  • Support the delivery of Clinical Safety and Pharmacovigilance services across a range of client projects.
  • Apply your technical expertise to help ensure high-quality, compliant safety deliverables.
  • Work closely with clients, colleagues, and cross-functional teams to support project success.
  • Contribute to continuous improvement initiatives and best practice sharing within the team.
  • Build your expertise across a broad range of Clinical Safety and Global Drug Safety activities.

Key Responsibilities

  • Perform Clinical Safety and Global Drug Safety activities in line with regulatory requirements, company procedures, and client expectations.
  • Support end-to-end case processing, safety reporting, literature monitoring, reconciliations, and related safety activities.
  • Contribute to the preparation and maintenance of safety-related documentation and project deliverables.
  • Support Safety Management Plans, Project Management Plans, and other project-specific documentation.
  • Assist with Regulatory Intelligence, XEVMPD activities, and other safety compliance initiatives as required.
  • Ensure assigned activities are delivered on time, to quality standards, and in accordance with project requirements.
  • Collaborate effectively with clients, vendors, and internal stakeholders across Quality & Compliance, Regulatory Affairs, Commercial, and other teams.
  • Support audit readiness activities, inspections, and CAPA actions when required.
  • Participate in process improvement initiatives and contribute to the development of best practices.
  • Maintain accurate project documentation and ensure systems and databases are kept up to date.
  • Participate in internal and external training to support ongoing professional development.


Requirements
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.


Benefits
  • 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.



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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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