Drug Safety Specialist

This is a remote position.

At Arriello, we provide Pharmacovigilance, Quality & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies, helping them meet regulatory requirements and protect patient safety.

Reporting directly to the Unit Lead for Safety Data Management, the Drug Safety Specialist plays a vital role in supporting case management activities and providing technical assistance across various units within the Pharmacovigilance (PV) department. The successful candidate will execute project-related tasks with precision, delegate effectively, and maintain a high standard of service quality.

Role Description:

• Execute project tasks specific to the unit, including but not limited to Global Individual Case Safety Report (ICSR) processing, Global Literature monitoring, Medicinal Product Management (XEVMPD), and Product documentation (SmPC,IB).
  
• Act as a Safety Data Coordinator for assigned projects, overseeing, coordinating, and delegating activities within the project team.
  
• Manage project-related PV contracts and escalate technical project issues as necessary.
  
• Support the improvement of processes within the assigned unit, ensuring smooth project execution and interdepartmental coordination.
  
• Provide administrative support to the department, including document management, project tracking, and communication with internal and external stakeholders.
  
  

Key Responsibilities:

• Work on projects and tasks assigned by management, ensuring excellence in project support and meeting deadlines.
  
• Act as a Process owner for assigned PV processes and provide training to team members as needed.
  
• Build effective working relationships with stakeholders and ensure compliance with processes and project deliverables.
  
• Participate in audits, inspections, and company marketing activities as required.
  
• Organize and maintain documents according to the company's document management system.
  
  

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.
  
• ​Demonstrated experience in post‑marketing and clinical study case processing.
  
• 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

• Work  remotely  while contributing to a  global life sciences consultancy .
  
• Lead  quality operations  that directly influence patient safety and regulatory compliance.
  
• Collaborate in a  multicultural, inclusive, and innovative environment.
  
• Enjoy opportunities for  career progression, professional development, and international exposure.
  
• 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   .