Senior Clinical Trial Drug Safety Associate I

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.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence.

Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs.

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 committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Trial Drug Safety Associate for our Toronto / Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada 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.

The project information may include the study protocol, SMP, Case Report Forms, Investigator’s Brochure, etc.

• 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, including case triage, data entry, narrative writing, and quality review of cases processed by other team members.

Case processing includes, but is not limited to, the following : 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;

includes 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.

Interacting with the Lead Data Manager to post queries to clinical database, where applicable, or directly with clinical study sites to obtain the missing case information.

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 that conform to Everest’s standards and regulatory requirements.

• 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, including authoring or peer review of SMPs and related attachments and forms.
• Participate in UAT including script development and testing, as applicable, and maintain validation documentation in accordance with governing documents.
• Generate safety data listings or reports from Argus for assigned clients for periodic and ad hoc reporting.
• Perform reconciliation activities to ensure consistency of safety data between clinical and safety databases.
• Ensure all safety-related documentation for client projects is properly filed (e.g., in the Argus Safety System and in the study Trial Master File TMF ).
• 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 (e.g., listings for IND / DSUR / Annual Reports), or other documents, as necessary.
• Act as a training resource to staff on case processing and the use of the Argus Safety System and associated case processing workflows.
• May provide technical support for the Argus Safety System, including assisting with safety database configurations for new and existing clients.
• 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 and Experience :

• 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 for investigational and marketed products.

Global PV regulation experience is preferred.

• Experience with safety case processing in clinical trials.
• Prior experience with a safety database including case processing and generating reports / line listings from the database;

Oracle Argus Safety database experience is preferred.

• Familiar with E2B (XML) format for safety reporting to regulatory agencies.
• Ability to work independently with little supervision; self-motivated and productive.
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging / conflicting deadlines.
• Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
• Detail-oriented, customer- and quality-focused.
• Strong attention to detail.
• Excellent interpersonal and teamwork skills.
• Computing skills in MS Office applications.
• Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
• Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions, is preferred.
Il y a plus de 30 jours