Fortrea

Fortrea

Associate II Patient Safety Solutions (PSS) Remote based in Canada

Toronto · Mid · Full-time

Sponsorship not specified$67k-$82kDetected 6 hours ago
Clinical TrialsPharmacovigilanceMicrosoft Office

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odds of building a lasting career here

15Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70

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About the role

  • This role requires strong clinical knowledge as well as an understanding of the US Healthcare system.
  • This is a full-time, home-based position in Canada that will require willingness to work flexible hours as needed to meet business needs.
  • In addition, you will be responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

Responsibilities

  • Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
  • Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
  • Support root cause analysis and CAPA plan development & implementation for identified quality issues as needed.
  • Support and/or participate in audits and inspections including the preparation as needed.
  • Demonstrate role-specific Core Competencies and company values on a consistent basis. Build and maintain good PSS relationships across functional units.

Requirements

  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Varied hours may be required.
  • Associate's degree RN + 2 years of Safety experience *
  • BS/BA + 1 years of Safety experience *
  • MS/MA + 1 years of Safety experience *
  • PharmD + 1 years of Safety experience *
  • Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
  • Experience (Minimum Required):
  • Ensure all cases that requiring expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines.

Compensation

  • CAD 67,000-82,000/ annually

Benefits

  • All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Equal opportunity

  • Learn more about our EEO & Accommodations request here.

This listing is sourced directly from Fortrea's careers page and normalized into a canonical job model.