Clinical Trial Drug Safety Associate I

2 weeks ago

Markham, Canada Everest Clinical Research Full time

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 a committed, skilled, and customer-focused individual to join our winning team as a **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**:

- Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
- 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).
- Perform PV activities in a timely manner according to regulatory and sponsor reporting requirements.
- Perform as the Lead Safety Associate for assigned trials, ensuring compliance with all PV requirements.
- Perform quality control (QC) review of case processing by other PV personnel.- Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports to ensure that redaction of personal identifying information has occurred, as necessary.
- Perform QC review of data in the safety database for cases entered by other PV personnel, ensuring data accurately reflects the relevant case details in the source documents.
- Review the patient narrative, ensuring it adheres to the narrative template and accurately describes the case details and 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 Argus.
- Interact with the Everest Medical Monitor to ensure the high quality of case narratives and regulatory report forms and that they conform to Everest’s standards and regulatory requirements.
- May generate regulatory report forms (MedWatch/CIOMS/E2B) for reportable events for clients’ submission to regulatory authorities and Investigators/Institutional Review Boards (IRBs).
- May also perform a data entry role in ICSR case processing, including generation of the case narrative.
- Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
- Review study-specific SMPs written by other PV personnel; occasionally draft SMPs.
- Perform reconciliation of safety data between clinical and safety databases.
- Perform UAT of safety database builds to ensure validation of the study and reporting configuration.
- May contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), Line Listings, or other documents, as necessary.
- Provide weekend/holiday coverage, on a rotating basis with other PV personnel, for case processing and management of cases requiring expedited reporting.
- Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
- Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
- Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

Qualifications:

- At least two years' drug safety experience in a pharmaceutical or clinical research environment.
- Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
- Experience with safety case processing of SAEs.
- Experience with an accepted clinical data capture and management system (preferred).
- Strong ve

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