Drug Safety Specialist - Clinical Safety

This is a remote position.

Drug Safety Specialist - Clinical Safety

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:

As a GDS Clinical Safety Specialist, you will play a pivotal role in ensuring the safety and compliance of clinical trials for our esteemed clients. The position executes project-related tasks and activities and is able to delegate activities to other team members within the unit (Global Drug Safety associate and Assistants) as and if required and ensures high quality of the services provided

Key Responsibilities:

• Execute various project tasks related to Global ICSR processing, Literature Monitoring, Signal Management, Benefit Risk Management, XEVMPD Medicinal Product Management, and more.
  
• Oversee and ensure high-quality work from project team members.
  
• Manage safety-related aspects of clinical trials, including SAE processing, SUSAR reporting, and safety data reconciliation.
  
• Organize meetings, collaborate cross-functionally, and support business development activities such as bid defenses and audits.
  
• Act as a process owner for assigned pharmacovigilance (PV) processes, providing training as required.
  
• Ensure compliance with regulatory requirements (ICH, GVP, GCP, CIOMS).
  
• Support the preparation of safety reports, including aggregate reports.
  
  

Requirements

• 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.
  

Benefits

• 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.
  
  

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 .