Clinical Trial Drug Safety Associate I

4 weeks ago

Markham, Ontario, Canada Clinical Research Training Academy Full time

Job Summary:

Everest Clinical Research is a full-service contract research organization (CRO) providing expertise-based clinical research services to pharmaceutical, biotechnology, and medical device industries. We serve top companies and work with advanced drugs, biologics, and medical devices in development.

Key Responsibilities:

  • Perform pharmacovigilance (PV) and medical device vigilance (MDV) activities for clients in compliance with company SOPs, working practices, and regulatory guidelines.
  • Train study-related materials on case processing of individual case safety reports (ICSRs) for clinical trials, including study protocols and Safety Management Plans (SMP).
  • Complete PV tasks timely according to regulatory and sponsor reporting requirements.
  • Lead safety associate for assigned trials, ensuring compliance with all PV requirements.
  • Review quality control (QC) of case processing by other PV personnel.
  • Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports for redaction of personal identifying information.
  • QC review of data in the safety database for cases entered by other PV personnel, ensuring data accurately reflects source documents.
  • Review patient narratives, ensuring they adhere to templates and accurately describe case details.
  • Generate queries for critical or missing information and send to Data Manager for posting to the clinical database or directly to study sites.
  • Filing and saving case documentation, including uploading source files into Argus.
  • Interact with Medical Monitor to ensure high-quality case narratives and regulatory report forms conform to Everest's standards and regulations.
  • Generate regulatory report forms (MedWatch/CIOMS/E2B) for reportable events for client submission to regulatory authorities and Investigators/Institutional Review Boards (IRBs).
  • Perform data entry role in ICSR case processing, including generation of case narratives.
  • Participate in design of SAE report forms for capturing safety data in clinical trials.
  • Review study-specific SMPs written by other PV personnel; occasionally draft SMPs.
  • Reconcile safety data between clinical and safety databases.
  • Perform user acceptance testing (UAT) of safety database builds to ensure validation of study and reporting configuration.
  • Contribute to preparation and review of additional regulatory reporting documents, as necessary.
  • Provide weekend/holiday coverage for case processing and management of cases requiring expedited reporting.

Qualifications:

  • Bachelor or Master's degree in Clinical or Medical or Life Sciences with experience in subject matter.
  • 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 serious adverse events (SAEs).
  • Experience with an accepted clinical data capture and management system (preferred).
  • Strong verbal and written communication skills with ability to understand and summarize medical terminology (preferred).
  • Good organizational skills with ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines (preferred).
  • Ability to maintain confidentiality with clinical data and client's proprietary data.
  • Detail-oriented, customer- and quality-focused.
  • Excellent interpersonal and teamwork skills.
  • Computing skills in MS Office applications.

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