Senior Clinical Trial Drug Safety Associate
Job Category: Pharmacovigilance and Drug Safety
Requisition Number: SENIO002037
Posted: March 8, 2024
Location: Sofia, Bulgaria
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Senior Clinical Trial Drug Safety Associate for our August Research location in Bucharest, Romania with opportunities to work remotely in accordance with our Work from Home policy.
Key Accountabilities:
- Assume a leader/mentorship role in the training of safety associates for PV and drug safety activities, ensuring compliance with PV processes and procedures as outlined in study level safety plans.
- Receive safety monitoring projects and project information from the direct manager or from the work mentor for the assigned PV projects.
- Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
- Provide support to case processing of SAEs and/or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner.
- Review of hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports and redaction as necessary.
- Entering case safety data into the safety database and generating queries for any critical or missing information.
- Writing patient narratives for ongoing PV projects.
- Interacting with the Lead Data Manager to post queries to clinical database, where applicable.
- Performing QC review of data in the safety database entered by another Safety Associate.
- Interacting with the Everest Medical Monitor to produce high quality case narratives and regulatory report forms.
- Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
- Provide operational support to study start-up PV activities.
- Participate in UAT including script development and testing.
- Generate safety data listings or reports from Argus for assigned clients.
- Perform reconciliation activities to ensure consistency of safety data.
- Ensure all safety-related documentation for client projects is properly filed.
- Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
- Contribute to the preparation and review of additional regulatory reporting documents.
- Act as a training resource to staff on case processing and the use of the Argus Safety System.
- May provide technical support for the Argus Safety System.
- Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
- Assist with new SOP development for PV procedures.
- Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
Qualifications:
- BS (or equivalent) degree in Clinical or Medical or Life Sciences.
- 4 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.
- Comprehensive understanding of FDA, Health Canada, and/or EU legislation and GCP/GVP/ICH safety guidelines.
- Experience with safety case processing in clinical trials.
- Prior experience with a safety database including case processing and generating reports.
- Familiar with E2B (XML) format for safety reporting to regulatory agencies.
- Ability to work independently with little supervision.
- Good organizational skills with the ability to manage multiple assignments.
- Strong verbal and written communication skills.
- Detail-oriented, customer- and quality-focused.
- Excellent interpersonal and teamwork skills.
- Computing skills in MS Office applications.
- Ability to maintain a high degree of confidentiality with clinical data.
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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