ICON plc is a leading global healthcare intelligence and clinical research organization that offers exciting career opportunities for individuals interested in shaping the future of clinical development. Currently, ICON is seeking a Pharmacovigilance Assistant I to join their team. This role offers a chance to be part of a dynamic organization that fosters innovation, inclusivity, and excellence in clinical research.
About the Role: Pharmacovigilance Assistant I
As a Pharmacovigilance Assistant I at ICON plc, you will play a crucial role in ensuring the safety and compliance of clinical trials and post-marketing surveillance. Your responsibilities will include handling safety notifications, tracking adverse events, and supporting safety reporting processes. You will be working closely with project teams to ensure accurate documentation and effective communication regarding medical safety and regulatory submissions.
Key Responsibilities
- Safety Reporting & Data Handling:
- Receive and distribute safety notifications (e.g., SAEs, hospital records) to relevant teams.
- Ensure proper data privacy protection when handling personal identifiers.
- Maintain accurate logs for SAEs and other tracking purposes.
- Documentation & Submissions:
- Prepare courier shipments and electronic safety submissions.
- Manage and upload documents to the Trial Master File (eTMF) and Safety Reporting Systems.
- Track and manage post-marketing safety data and complete necessary reporting tasks.
- Support to Project Teams:
- Organize meetings, prepare agendas, and maintain project-specific documentation.
- Assist with financial tasks, including managing purchase orders and invoices.
- Ensure project-related information is filed correctly in a timely manner.
- Additional Duties:
- Assist with translation management, mailbox surveillance, and SAE Hotline testing.
- Maintain departmental calendars, manage project-specific trainings, and perform offsite archiving.
- Track and update project metrics and training compliance.
Qualifications and Skills Required
- Education: A degree in Pharmacy or related field (MPharm or similar).
- Experience: Prior experience in pharmacovigilance or clinical safety is a plus, though entry-level candidates may also apply.
- Skills:
- Proficiency in Microsoft Office (Windows, MS Word, Excel, PowerPoint).
- Strong organizational skills, attention to detail, and ability to handle multiple tasks simultaneously.
- Excellent communication skills, both verbal and written.
- Knowledge of safety reporting systems and regulatory guidelines is beneficial.
