Clinical Trial Drug Safety Specialist I

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Conduct pharmacovigilance (PV) and medical device vigilance (MDV) tasks for clients in adherence to company SOPs, operational practices, and regulatory standards.

• Provide training on study-related materials for handling Individual Case Safety Reports (ICSRs), which include study protocols and Safety Management Plans.

• Receive, monitor, triage, and log serious adverse event, device incident, and pregnancy reports into the Argus safety database.

• Evaluate, assess, and manage cases from ongoing clinical trials related to drugs or devices.

• Review report forms and accompanying documents; redact personal identifying information when required.

• Input relevant case information into Argus.

• Draft patient narratives utilizing demographic data, medical history, concomitant medications, and adverse event information.

• Create and dispatch queries for critical or missing data.

• Organize and archive case documentation, including uploading source files.

• Conduct quality control reviews of safety database entries made by other PV staff.

• Execute user acceptance testing for safety database builds.

• Participate in the design of serious adverse event report forms.

• Review study-specific Safety Management Plans.

• Aid in reconciling safety data between clinical and safety databases.

• Provide rotating weekend and holiday coverage for case processing and expedited reporting.

• Ensure adherence to applicable regulations and timelines for safety case processing and reporting.

• Stay updated with guidance and regulations concerning pharmacovigilance and medical device vigilance.

• Plan and oversee deliverables and timelines in accordance with clinical trial project team requirements.

⛳️ Requirements

• A Bachelor’s degree in Clinical, Medical, or Life Sciences is required.

• Experience in Phase I through Phase IV clinical trials, with knowledge of drug/medical device safety regulations and industry standards, is advantageous.

• Prior exposure to pharmacovigilance processes is a plus.

• Strong organizational skills with the capacity to adapt to shifting priorities and manage multiple assignments under challenging deadlines (preferred).

• Excellent verbal and written communication abilities, with the capability to comprehend and summarize medical terminology (preferred).

• Ability to uphold a high level of confidentiality regarding clinical data and proprietary client information.

• Detail-oriented, with a focus on customer service and quality.

• Strong interpersonal and teamwork skills.

• Proficient in MS Office applications.

🏝️ Benefits

• Remote work setup.

• Rotating weekend and holiday coverage (job-related scheduling arrangement).

• Equal opportunity and accommodations for candidates with disabilities.