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 a Senior Director, Pharmacovigilance and Drug Safety 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 Responsibilities
Trial Safety Management: Direct the operational delivery of clinical trial safety services, including the processing, medical review, and tracking of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
Sponsor Delivery: Ensure all active clinical trials meet client-specific Service Level Agreements (SLAs), Key Performance Indicators (KPIs), and Safety Management Plans (SMPs).
Investigator & Committee Support: Oversee the timely preparation and distribution of Investigator Letters, expedited safety reports, and data feeds for Data Monitoring Committees (DMCs/DSMBs).
Phase 2 Infrastructure (Global Scale): Formulate the roadmap to expand post-marketing services globally, adapting systems to support multi-lingual intake, EU/UK QPPV networks, and diverse international regulatory frameworks.
SOP & SDEA Frameworks: Author and launch a comprehensive suite of post-marketing Standard Operating Procedures (SOPs) and Safety Data Exchange Agreement (SDEA) templates, initially aligned with FDA 21 CFR 314/600 and systematically upgraded to meet Global Good Pharmacovigilance Practices (GVP).
Capabilities Building: Establish operational workflows for global literature screening, localized digital media safety monitoring, and multi-regional aggregate report compilation.
Aggregate Document Delivery: Collaborate with Regulatory Strategy and Submissions team and with Medical and Scientific Writing service areas for the authoring and submission of periodic regulatory documents bridging pre- and post-marketing formats (e.g., DSURs, PADERs, PBRERs).
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