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Clinical Safety Senior Specialist

Role overview

Qualifications

  • Bachelor's degree in Pharmacy, Medicine, Life Sciences, Pharmaceutical Sciences, or a related discipline
  • Minimum 4 years of experience in Clinical Safety, Pharmacovigilance, or Global Drug Safety
  • Strong knowledge of global Drug Safety regulations, processes, and guidelines (ICH, GVP, GCP, CIOMS)
  • Experience managing Clinical Safety activities, including case processing oversight, literature monitoring, safety documentation, and regulatory compliance

Responsibilities

  • Lead and oversee a broad range of clinical safety and pharmacovigilance activities across client projects
  • Act as a technical lead, ensuring project deliverables are completed to the highest standards of quality, compliance, and accuracy
  • Provide technical guidance and support to project teams, helping to resolve complex challenges and drive successful outcomes
  • Support project managers with delivery oversight, risk identification, mitigation planning, and escalation management

Key facts

Other skills

  • Communication
  • Organizational Skills
  • Consulting
  • Collaboration
  • Problem Solving

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 Senior 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 Senior Clinical Safety Specialist, you will be a trusted technical expert within our Global Drug Safety team, helping to ensure the highest standards of patient safety while supporting the successful delivery of complex global client programmes.

This is an opportunity for an experienced pharmacovigilance professional who enjoys combining deep technical expertise with leadership, collaboration, and project oversight. You will play a key role in guiding safety activities across multiple projects, supporting operational excellence, and acting as a technical partner to clients and internal stakeholders.

Beyond project delivery, you will help shape how we work by driving process improvements, mentoring colleagues, supporting audit readiness, and contributing to the continued growth and development of our Global Drug Safety function.

If you are looking for a role where you can influence outcomes, share your expertise, and make a meaningful contribution to patient safety on a global scale, this could be the perfect next step in your career.

What You Will Be Doing

In this role, you will:

  • Lead and oversee a broad range of clinical safety and pharmacovigilance activities across client projects.
  • Act as a technical lead, ensuring project deliverables are completed to the highest standards of quality, compliance, and accuracy.
  • Provide technical guidance and support to project teams, helping to resolve complex challenges and drive successful outcomes.
  • Support project managers with delivery oversight, risk identification, mitigation planning, and escalation management.
  • Build trusted partnerships with clients, vendors, and cross-functional teams across Quality & Compliance, Regulatory Affairs, Commercial, and other functions.
  • Drive operational excellence through continuous improvement initiatives and process optimisation.
  • Act as a subject matter expert for assigned Global Drug Safety processes.
  • Mentor and develop junior colleagues, supporting capability building across the wider team.
  • Contribute to client meetings, proposal support activities, audits, inspections, and business growth initiatives.


Requirements

Essential Skills & Experience

  • Bachelor's degree in Pharmacy, Medicine, Life Sciences, Pharmaceutical Sciences, or a related discipline.
  • Minimum 4 years of experience in Clinical Safety, Pharmacovigilance, or Global Drug Safety.
  • Strong knowledge of global Drug Safety regulations, processes, and guidelines (ICH, GVP, GCP, CIOMS).
  • Experience managing Clinical Safety activities, including case processing oversight, literature monitoring, safety documentation, and regulatory compliance.
  • Experience supporting complex projects, managing priorities, timelines, risks, and stakeholder expectations.
  • Knowledge of audits, inspections, CAPA management, and quality systems.
  • Experience working cross-functionally with clients, vendors, and internal stakeholders.
  • Experience mentoring, training, or providing technical support to colleagues.
  • Strong communication, organisational, and problem-solving skills.
  • Fluent written and spoken English.

Nice to Have

  • Experience with Veeva Vault Safety.
  • Experience across both clinical trial and post-marketing environments.
  • Experience within a consultancy, CRO, or outsourced services environment.
  • Experience supporting proposals, client presentations, or business development activities.


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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