Advanced Clinical is hiring a Safety Assistant in Ahmedabad, Gujarat, India. This is a great opportunity for candidates with experience in drug safety, pharmacovigilance, and clinical trials to join a leading global contract research organization (CRO).
If you’re detail-oriented, passionate about clinical research, and eager to support global safety services, this role offers a strong platform to grow your career.
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📝 Job Responsibilities
As a Safety Assistant, you will:
- Follow applicable Standard Operating Procedures (SOPs).
- Assist in creating and maintaining safety documentation (training materials, safety forms, management plans).
- Provide administrative support to the Global Safety Services (GSS) team.
- Monitor safety mailboxes, redact and file incoming safety data, assign cases, and acknowledge reports.
- Perform initial triage and data entry into safety databases.
- Update and maintain safety trackers.
- Prepare and quality-check final Serious Adverse Event (SAE) packages for filing in the Trial Master File (TMF).
- Collaborate with clinical sites, reporters, and internal teams on safety matters.
- Ensure compliance with ICH GCP, global privacy laws, and regulatory requirements.
- Support safety training for study teams as needed.
🎓 Qualifications
To be eligible, you should have:
- 1+ years of experience as a Safety Assistant or Safety Coordinator (CRO experience preferred).
- Experience working with global safety teams.
- Proficiency in Veeva Vault Safety, ARISg (LifeSphere MultiVigilance), MS Office Suite, and Adobe Acrobat.
- Strong organizational and time-management skills.
- Knowledge of clinical research, pharmacovigilance, and drug/device safety regulations.
🌟 Benefits of Joining Advanced Clinical
- Work with a global leader in clinical research.
- Exposure to diverse therapeutic areas and regulatory landscapes.
- Inclusive and diverse workplace culture.
- Career growth and professional development opportunities.
📌 How to Apply
