Clinical Trial Drug Safety Specialist I

Everest has been a CRO since January 2004 with a strong foundation as a statistical, programming, and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Headquartered in Toronto, Canada, with subsidiary offices in New Jersey, USA; Shanghai, China; Taipei, Taiwan; Bulgaria, Romania, Poland, and Croatia in Europe. Everest continues to deepen capabilities and serve highly satisfied customers in data/analytics services and full-service execution with quality, effectiveness, and agility for worldwide clinical trials. Growing steadily over 21 years, Everest is a preferred vendor for 100+ active clients, including major, mid-sized, and small pharmaceutical, biotech, and medical device companies. We value our clients and all growth to date is primarily from their repeat and referral business. We are known for our high-touch approach with client teams, high quality standards, customer-focus, “can-do” culture, advanced technology utilization, and continuous improvement. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that’s us…that’s Everest. To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as an Clinical Trial Drug Safety Specialist I in Sofia, Bulgaria. Key Accountabilities: 1. Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines. 2. Perform training of study related materials related to case processing of ICSRs for a clinical trial, including the study protocol and Safety Management Plan (SMP). 3. Perform PV activities in a timely manner according to regulatory and sponsor reporting requirements. 4. Receive and track new SAE, device incident, and pregnancy reports, triage the reports, and book the cases into the Argus safety database. 5. Review, assess, and process cases from clients’ ongoing drug or device clinical trials. * Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports; perform redaction of personal identifying information, as necessary. * Perform data entry of the cases into Argus ensuring all relevant case details are entered in the appropriate fields. * Write patient narratives for ongoing PV projects, adhering to the narrative template; include review of patient data such as demographic, medical history, concomitant medication, and adverse event (AE) data in order to write a narrative that is up-to-date, complete, and concise. * Generate queries for any critical or missing information. Send queries to the Data Manager for posting to the clinical database and/or generate Data Clarification Forms (DCFs) and send queries directly to the study sites. * Ensure all case documentation is filed and saved appropriately, including uploading of source files into 6. May perform quality control review of data in the safety database for cases entered by other PV personnel. 7. Perform UAT of safety database builds to ensure validation of the study and reporting configuration. 8. May participate in the design of SAE report forms for the capturing of safety data in clinical trials. 9. May review study-specific SMPs written by other PV personnel. 10. May assist with reconciliation of safety data between the clinical and safety databases. 11. Provide weekend/holiday coverage, on a rotating basis with other PV personnel, for case processing and management of cases requiring expedited reporting. 12. Ensure compliance with all applicable regulations and timelines for safety case processing and reporting. 13. Keep current with industry best working practices in PV/MDV guidance(s) and regulations. 14. Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements. Qualifications: 1. At least a Bachelor degree in Clinical or Medical or Life Sciences. 2. Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards is an asset. 3. Prior experience with pharmacovigilance processes is an asset. 4. Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines (preferred). 5. Strong verbal and written communication skills with the ability to understand and summarize medical terminology (preferred). 6. Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data. 7. Detail-oriented, customer- and quality-focused. 8. Excellent interpersonal and teamwork skills. 9. Computing skills in MS Office applications. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com [https://www.ecrscorp.com/] 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. #LI-MM1