Drug Safety Specialist

4 weeks ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
About the Role

We are seeking a highly skilled and customer-focused individual to join our team as a Clinical Trial Drug Safety Associate at Everest Clinical Research Services Inc.

Key Responsibilities
  • Perform Pharmacovigilance (PV) and Medical Device Vigilance (MDV) activities for our clients in compliance with company Standard Operating Procedures (SOPs), working practices, and regulatory guidelines.
  • Train study-related materials related to case processing of Individual Case Safety Reports (ICSRs) for clinical trials, including the study protocol and Safety Management Plan (SMP).
  • Perform PV activities in a timely manner according to regulatory and sponsor reporting requirements.
  • Lead Safety Associate for assigned trials, ensuring compliance with all PV requirements.
  • Perform quality control (QC) review of case processing by other PV personnel, ensuring data accurately reflects the relevant case details in the source documents.
  • Review patient narratives, ensuring they adhere to the narrative template and accurately describe the case details.
  • Generate queries for critical or missing information and send them to the Data Manager for posting to the clinical database.
  • Ensure all case documentation is filed and saved appropriately, including uploading of source files into Argus.
  • Interact with the Everest Medical Monitor to ensure high-quality case narratives and regulatory report forms.
  • Generate regulatory report forms (MedWatch/CIOMS/E2B) for reportable events for clients' submission to regulatory authorities and Investigators/Institutional Review Boards (IRBs).
  • Perform 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 and occasionally draft SMPs.
  • Perform reconciliation of safety data between clinical and safety databases.
  • Perform User Acceptance Testing (UAT) of safety database builds to ensure validation of the study and reporting configuration.
  • Contribute to the preparation and review of additional regulatory reporting documents, as necessary.
  • Provide weekend/holiday coverage for case processing and management of cases requiring expedited reporting.
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Stay 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.
Requirements
  • Bachelor or Master's degree in Clinical or Medical or Life Sciences with experience in the 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 SAEs.
  • Experience with an accepted clinical data capture and management system (preferred).
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology (preferred).
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines (preferred).
  • Ability to maintain a high degree of 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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