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Project Leader Medical Safety -Toronto, Canada. Best #101

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Project Leader Medical Safety -Toronto, Canada. Drives the process for the collection, assessment, reporting and filing of adverse events from both pre and post marketing products

Requisition Start Date: ASAP

Employment Type: Full-Time, Permanent Position

Location: Toronto, Ontario

DataStage Jobs, Admin – Toronto, Canada.


Project Leader Medical Safety . Responsibilities

  • Drives the process for the collection, assessment, reporting and filing of adverse events from both pre and post marketing products
  • Processes serious adverse event data from event data from clinical trials and adverse events.
  • Coordinates the Medical Safety activities for the preparation of deliverables such the annual IND, DSUR, IBs and DSMB reports.
  • Assists with the development and maintenance of Risk Management Plans.
  • User administration, approvals and technical expertise for the Safety Database.
  • Prepares safety outputs for Inclusion in Clinical Study Reports and Integrated Safety summaries.
  • Establishes work plans, schedules wok and assigns to business partners involved in PV activities and safety surveillance as required.
  • Liaises with CDM, Regulatory Affairs and Clinical Research to ensure PV project timelines are met and that Pharmacovigilance regulations/guidelines for both domestic and international markets are followed.

Technical Project Manager – Toronto.

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Project Leader Medical Safety . Requirements

  • B.A. or Msc. In Pharmacy, Nursing or related health sciences preferred.
  • Minimum 5 years pharmacovigilance experience.
  • In depth understanding of relevant safety and pharmacovigilance guidelines as well as relevant clinical trials regulations.
  • Experience with safety databases (ARGUS preferred).
  • Experience with medical terminology (e.g. MedDRA and WHODRUG).
  • Demonstrated ability with computer software packages; MS Office Suite, Adobe Acrobat Exchange and Safety Database software.
  • Strong interpersonal and verbal/written communication skills.
  • Demonstrated effective organization and time-management skills. Ability to manage multiple priorities in an efficient manner under pressure.
  • Proven ability in the implementation of new initiatives and receptive to change in demands and workload.
  • Ability to establish and maintain effective working relationships with coworkers, management and customers

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Seniority Level

Mid-Senior level


  • Pharmaceuticals
  • Biotechnology
  • Medical Device

Employment Type


Job Functions

  • Other
  • Project Management
  • Science

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