Drug Safety Senior Specialist

Arriello; Poland; Remote; PLN 180,000 - 280,000; Full time

Job summary

Arriello in Poland seeks a Senior Clinical Safety Specialist to join our Global Drug Safety team in a remote, international role. You will provide expert technical leadership across multiple client programmes, guiding safety activities and ensuring high-quality pharmacovigilance deliverables.

You will mentor colleagues, drive process improvements, support audits, and collaborate with clients and vendors to maintain patient safety at the centre of every project.

Qualifications

• Bachelor's degree in Pharmacy or Life Sciences.
• Minimum 4 years in Clinical Safety or Pharmacovigilance.
• Strong knowledge of global Drug Safety regulations (ICH, GVP, GCP, CIOMS).
• Experience overseeing case processing, literature monitoring, and safety documentation.
• Experience cross-functional collaboration with clients and vendors.
• Fluent written and spoken English.

Responsibilities

• Provide technical leadership on safety activities across client projects.
• Oversee end-to-end case processing, safety reporting, and literature monitoring.
• Develop and maintain Safety Management Plans and related documents.
• Support audit readiness and CAPA management.
• Mentor junior team members and promote continuous improvement.
• Collaborate with Quality & Compliance, Regulatory Affairs and Project Management teams.

Skills

Pharmacovigilance expertise

Regulatory knowledge

Leadership & mentoring

Communication skills

Project oversight

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy or related Life Sciences

Tools

Veeva Vault Safety

Job description

• Industry Pharma/Biotech/Clinical Research
• Remote Job

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

• Serve as a senior technical member of the Global Drug Safety team, supporting the delivery of high-quality Clinical Safety services.
• Lead and oversee safety activities across a diverse portfolio of client projects.
• Act as a trusted technical expert, providing guidance to colleagues and stakeholders.
• Support project delivery, quality compliance, and operational excellence.
• Build strong relationships with clients, vendors, and cross-functional teams.
• Mentor and develop junior team members while helping to drive continuous improvement.

Key Responsibilities

• Perform and oversee Clinical Safety and Global Drug Safety activities, ensuring compliance with regulatory requirements and client expectations.
• Provide technical oversight of end-to-end case processing, safety reporting, literature monitoring, reconciliations, and safety deliverables.
• Develop, review, and maintain Safety Management Plans, Project Management Plans, and other safety-related documentation.
• Support Signal Management, Benefit-Risk Management, Regulatory Intelligence, and XEVMPD activities where required.
• Act as a technical lead on assigned projects, supporting delivery planning, timelines, priorities, and issue resolution.
• Identify, escalation and support mitigation of project and compliance risks.
• Contribute to RFI and QAQ questionnaires, proposals, and client-facing activities.
• Act as Process Owner for assigned Global Drug Safety processes and support procedural improvements.
• Support audit readiness, inspections, CAPA management, and quality compliance initiatives.
• Collaborate closely with clients, vendors, and internal stakeholders including Quality & Compliance, Regulatory Affairs, Commercial, and Project Management teams.
• Provide mentoring, training, and technical support to junior team members.
• Promote best practices, knowledge sharing, and continuous improvement across the Global Drug Safety function.

Requirements

• 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.
• 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.

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.