Drug Safety Specialist Local PV

This is a remote position.

Global Drug Safety Specialist 

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.

We are a growing business with a collaborative culture focused on high‑quality delivery, continuous improvement, and giving people the space to do their best work.

Our values guide how we work:

• 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
  

We are seeking a Global Drug Safety Specialist based in Portugal to join our team and play a key role in managing technical and project-related activities within the Global Drug Safety department. You will be responsible for local project management, including literature monitoring, ICSR processing, and compliance reporting. This role also requires close collaboration with cross-functional teams and may involve the management of junior staff.

• Lead local project management, including local literature monitoring, ICSR processing, LPPV/LSO management, and monthly reporting and compliance monitoring.
  
• Process safety reports (AEs, SAEs, SUSARs) from all sources, including receipt, coding, and submission.
  
• Support reconciliation of safety reports with clinical databases and assist in medicinal product management (XEVMPD).
  
• Manage safety data exchange agreements and contribute to the development of product documentation (SmPC, IB).
  
• Support signal management and benefit-risk evaluation activities.
  
• Provide training and technical guidance to project teams and junior members of the Global Drug Safety department.
  
• Monitor project-specific safety mailboxes, track compliance, and maintain organized project files.
  
• Collaborate with internal stakeholders (e.g., Regulatory, Quality, Commercial) and external stakeholders (e.g., clients, authorities).
  
• Participate in audits, inspections, client meetings, and company marketing or promotional activities as required.
  
• Identify and implement process improvements to enhance efficiency and quality across projects.
  

Requirements

• Bachelor's degree in pharmaceutical sciences, life sciences, or related field (advanced degree preferred).
  
• Minimum 3 years of experience in a drug safety or medical department with strong knowledge of medical terminology and safety regulations (ICH, GVP, GCP).
  
• Experience in Local PV, preferably as LPPV would be an advantage.
  
• Fluent English (verbal and written) are required. A second European Language preferred.
  
• Strong understanding of local and global drug safety processes, with significant experience in safety databases.
  
• Excellent organizational, time-management, and communication skills.
  
• Ability to manage multiple priorities, meet deadlines, and work effectively in a team environment.
  

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.
  
  

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 .