Advanced Clinical is a leading clinical development and strategic resourcing organization dedicated to improving the clinical research experience. With decades of expertise, we support pharmaceutical, biotech, and medical device companies in achieving better clinical outcomes. Our mission is to enhance the lives of those impacted by clinical research through foresight, innovation, and resilience.
We foster a diverse and inclusive workplace, valuing different perspectives to drive efficiency and effectiveness. Advanced Clinical is an Equal Opportunity Employer, committed to non-discrimination based on race, gender, age, religion, disability, or any other protected status.
Job Description
The Safety Assistant plays a crucial role in ensuring the accurate collection, tracking, and storage of clinical trial and post-marketing safety data. This position involves administrative support for the Global Safety Services (GSS) team, including monitoring safety mailboxes, managing documentation, and assisting with regulatory submissions.
Key Responsibilities:
✔ Monitor Safety Mailboxes & Databases: Track incoming safety data, redact sensitive information, and file documents appropriately.
✔ Data Entry & Tracking: Perform initial triage and data entry into safety databases (e.g., Veeva Vault, ARISg) and maintain safety trackers.
✔ SAE Documentation: Prepare and quality-check Serious Adverse Event (SAE) packages for Trial Master File (TMF) filing.
✔ Regulatory Compliance: Ensure adherence to ICH GCP, global privacy laws, and regulatory requirements for drug/device safety reporting.
✔ Collaboration: Liaise with medical teams, clinical sites, and project teams on safety-related matters.
✔ Training Support: Assist in providing safety training to study teams when required.
Qualifications & Skills:
✅ 1+ years of experience as a Safety Assistant, Safety Coordinator, or similar role (CRO experience preferred).
✅ Familiarity with safety databases like Veeva Vault Safety, ARISg (LifeSphere MultiVigilance).
✅ Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.
✅ Strong organizational skills with the ability to work under tight deadlines.
✅ Experience in a global team environment is a plus.
Why Join Advanced Clinical?
🔹 Inclusive Work Culture: We value diversity and encourage professional growth.
🔹 Impactful Work: Contribute to life-changing clinical research and drug development.
🔹 Career Development: Opportunities for training and advancement in pharmacovigilance and clinical safety.
