Safety Specialist - Remote

Overview

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

In Short

• Support to Company Staff for various activities according to legislation and procedures.
• Check SAE/eSAE received in sponsored Clinical trials, interacting with Clinical Operations CROs.
• Management of pregnancy cases.
• Management of follow-up requests to Clinical Operations CROs.
• Overall SAEs monitoring and tracking.
• Interaction with the Company Global Pharmacovigilance Service Provider (PVSP).
• Support in preparation of documentation for safety reporting submissions.
• Support in SAE reconciliation activities.
• Other activities connected with PV management in clinical trials.
• Management of study-specific activities according to legislation and procedures.

Requirements

• Master’s degree in science, medicine, biology, pharmacy or related fields.
• Background in Pharmacovigilance is a plus.
• Clear communication skills in English and Italian.
• Good documentation practices.
• Self-motivated and displays initiative.
• Experience working as part of a large team.
• Effective collaboration with team members.
• Proven organizational skills.
• Proficient in multiple computer applications including Microsoft Office.
• Attention to detail.

Benefits

• Opportunity to work with a global CRO.
• Career development opportunities.
• Supportive company culture.
• Work from home flexibility.
• Engagement in high-quality clinical development.