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Pharmacovigilance Safety Manager, Toronto/Markham, Ontario, Canada (on-site) Location

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 Pharmacovigilance Safety Manager for our Toronto/Markham, Ontario, Canada (on-site) location.

Key Accountabilities:

The Pharmacovigilance Safety Manager will be responsible for supporting the management of all pharmacovigilance (PV) activities under the direction of the Manager, Medical Writing and Clinical Safety Monitoring. This position will provide technical expertise for our Argus Safety Database, operational support for PV processes, and will be responsible for tracking and monitoring metrics for compliance with PV process activities according to client and global regulatory requirements.

  1. Provide technical support for the Argus Safety System, including assisting with safety database configurations for new and existing clients.

  2. Participate in User Acceptance Testing (UAT) including script development and testing, as applicable, and maintain validation documentation in accordance with governing documents.

  3. Generate safety data listings or reports from Argus for assigned clients for periodic and adhoc reporting.

  4. Become a subject matter expert in the Argus safety system. Act as a departmental resource by researching and consulting internally and/or with Oracle to resolve issues within the system.

  5. Provide operational support to study start-up PV activities, including authoring or peer review of Safety Management Plans (SMPs) and related attachments and forms.

  6. Provide support to case processing of SAEs, on an as needed basis, including case triage, data entry, narrative writing, and quality review of cases processed by other team members.

  7. Track all cases through the PV workflow and monitor adherence to processing timelines as detailed in the SMP and according to client and global regulatory requirements; and escalate case processing issues.

  8. Monitor compliance metrics for assigned projects to ensure regulations and timelines are being met for both expedited and periodic reporting.

  9. Ensure all safety-related documentation for client projects is properly filed (e.g., in the Argus Safety System and in the study TMF).

  10. Monitor and track adherence of PV processes according to Everest SOPs and Work Instructions.

  11. Oversee reconciliation of safety data for multiple studies with internal or external data management teams.

  12. Act as a training resource to staff on the use of the Argus Safety System and associated case processing workflows.

  13. May participate as an Administrator of safety data review committees and meetings (e.g., Data Monitoring Committee [DMC]/Data and Safety Monitoring Board [DSMB]).

  14. Assist with the generation and review of PV governing documents such as SOPs, Policies, and Work Instructions.

  15. Ensure PV processes are in compliance with all ICH-GCP guidelines, current US and global regulations, and contractual agreements with our clients.

  16. Maintain a high level of understanding of applicable PV Regulatory regulations (FDA and ICH guidance, GCP regulations; EU Directives, etc.) to assist in ensuring adherence to all requirements.

Qualifications and Experience:

  1. BS (or equivalent) degree in Clinical or Medical or Life Sciences.

  2. 5-8 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.

  3. Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products. Global PV regulation experience is preferred.

  4. Experience with safety case processing in clinical trials.

  5. Prior experience with Oracle Argus Safety database, including case processing and generating reports/line listings from the database.

  6. Familiar with E2B (xml) format for safety reporting to regulatory agencies.

  7. Ability to work independently with little supervision; self-motivated and productive.

  8. Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.

  9. Strong verbal and written communication skills with the ability to understand and summarize medical terminology.

  10. Detail-oriented, customer- and quality-focused.

  11. Strong attention to detail.

  12. Excellent interpersonal and teamwork skills.

  13. Computing skills in MS Office applications.


How to Apply:

Please send your application along with cover letter to [email protected]

To find out more about Everest Clinical Research and to review other opportunities, please visit our WEB site 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.

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