Senior Clinical Trial Safety Associate

Everest Clinical Research
Markham ON / Remote
30+ days ago

Job Description

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 Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China.

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 a committed, skilled, and customer-focused individual to join our winning team as Senior Clinical Trial 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 clinical safety monitoring 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 safety monitoring 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.
    • Write patient narratives for ongoing PV and/or medical writing 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.
    • Interact 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 adhoc 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., 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 Everest medical writing group by occasionally performing internal QC procedures, according to Everest’s Medical Writing Guidance Documents, for medical writing products such as protocols, clinical study reports (full, abbreviated, or synoptic), statistical reports, and other documents intended for regulatory submission.
  • 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:

  • B.Sc. (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.


To find out more about Everest Clinical Research and to review other opportunities, please visit our website at 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-Remote
#LI-KD1

Source

https://ca.indeed.com/jobs

Not sure if you qualify?

Uvaro is here to help you land great jobs like this one.

Upgrade your skills

Other Jobs

Miovision

Miovision provides cities with modern tools to fix today's traffic problems. We offer solutions that collect multimodal traffic data and uncover actionable insights, helping municipalities get more out of their road network. The result: streets capable of moving more people – safely and efficiently – whether they are in a car, on a bus, on a bike or e-scooter, or walking. Since 2005, our systems have counted more than nine billion vehicles around the world. We have offices in Kitchener, Canada as well as operations in Germany, Serbia and the US. For more information, visit miovision.com [http://miovision.com/]. Position Summary  The Sales Engineer (SE) is an industry expert that drives software growth by developing technical and operational relationships with customers in support of their adoption of the Miovision products.  As a technical industry expert, the SE integrates into the daily operation of the agency to support complex proof of concepts and ongoing initiatives to maximize product output and value.  The SE ensures continuous value and product adoption that ultimately drives intersection network and software growth. Key Accountabilities  * Create customer success plans to drive growth for each account  * Support solution design and technical implementation of current desired integrations as outlined in the customer success plan. * Monitor user adoption and product utilization and create targeted programs to increase engagement and support the agency's change management process. * Build strong relationships between the Miovision product and support teams to ensure continuous resolution of ongoing operational issues as well as product deficiencies that may come up.  * Participate in regular support and health checks to ensure accounts are continuing to derive value from our solutions * Support software renewal and upselling activities  Skills/Qualifications * Bachelor’s degree or recognized equivalency or achievement of recognized professional level * 5+ years of technical experience; must understand network products * Ability to travel internationally, providing on-site consulting work to clients * Ability to manage multiple projects utilizing strong planning and organizational skills * Experience with general consulting skills that include team facilitation, business case development, strong business analysis skills, process mapping and process redesign * Systems implementation skills: requirements/process analysis, conceptual and detailed design, configuration, testing, training, change management and support * Analytical nature with the ability to solve complex business issues * Basic understanding of product development and engineering processes.  We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Please indicate if you require accommodation on your application, and our team will work with you to meet your accessibility needs.

 
Remote
Uvaro

Recruit and train new sales staff, assign specific tasks to members of the sales team, and monitor the team's sales performance.

 
Waterloo, ON / Remote
Uvaro

Experience working as an SDR or BDR. Provide guidance and feedback on email outreach and sales calls. Experience working in a sales enablement function is a…

 
Waterloo, ON / Remote