Medical/Clinical Safety Specialist - Remote

Overview

Join our global Pharmacovigilance team as a Medical/Clinical Safety Specialist.

In Short

• Responsible for compliance with the Quality Management System.
• Participate in the collection and reporting of safety information.
• Interact with local Competent Authorities and partners.
• Process ICSRs and Serious Adverse Events from clinical trials.
• Oversee the preparation of regulatory safety documents.
• Collaborate with various functions for timely reporting.
• Act as a local contact for pharmacovigilance.
• Monitor national/regional pharmacovigilance regulations.
• Support continuous safety profile monitoring.
• Participate in inspections and audits as required.

Requirements

• Experience in pharmacovigilance and safety reporting.
• Knowledge of regulatory compliance in the EU.
• Strong communication skills.
• Ability to work in a team environment.
• Detail-oriented with strong analytical skills.
• Experience with clinical trials is preferred.
• Ability to manage multiple projects.
• Proficiency in relevant software and databases.
• Fluency in English; additional languages are a plus.
• Willingness to participate in inspections and audits.

Benefits

• Opportunity to work in a global team.
• Professional development opportunities.
• Flexible working environment.
• Competitive salary and benefits package.
• Supportive company culture.