Senior Specialist, Patient Safety Solutions - Remote based in Canada

Fortrea is currently seeking a remote based Senior Specialist (Patient Safety Solutions) to assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). 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.What You Will Do The Senior Specialist, PSS will manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. This role is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The Senior Specialist, PSS will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities

• Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, listed assessment against appropriate label (for Marketed products, if applicable).
• Manage submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partner and Labcorp project personnel, if required and as agreed with client during study set-up, within study specified timelines.
• Ensure all cases that require expediting reporting to worldwide Regulatory Agencies or other recipients are prioritised for processing and submission within the regulatory and/or study specific applicable timelines.
• Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report. (DSUR), Periodic Reports (PRs) line listings, and aggregate reports.
• May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
• Participate in signal detection, trend and pattern recognition activities, as appropriate.
• Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR), Periodic Reports (PRs) line listings, and aggregate reports.
• Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as a lead contact for projects including global projects ensuring communication and process harmonization.
• Work with Data Management or client on reconciliation of safety databases, if appropriate.
• Prepare and deliver safety presentations- o Serious Adverse Event reporting at Investigator meetings o Client capabilities meetings, as appropriate o “Department Overview” to internal clients.
• Maintains a comprehensive understanding of Labcorp PSS Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
• Participate or contribute to the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
• Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed and contribute towards training material development and updates.
• Contribute to preparation of Safety Management Plans (SMPs), Reconciliation Plans and other safety- specific plans under supervision.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.
• Participate in client or regulatory audits, and support preparation if needed.
• Actively support quality issue resolution and implementation of process improvement initiatives/activities.
• Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
• Assist with the set-up of, and the provision of data to Safety Committees/DSMBs and assist in the co-ordination of endpoint committees, as required.
• Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.
• All other duties as needed or assigned.

Qualifications (Minimum Required)

• Non-degree + 4 years of Safety experience* or 5-6 yrs of relevant experience**
• Associate degree + 3 years of Safety experience* or 4-5 yrs of relevant experience**
• BS/BA + 3 years of Safety experience* or 3-4 yrs of relevant experience**
• MS/MA + 2 yrs of Safety experience* or 3 yrs of relevant experience** PharmD + 2 yrs of Safety experience* or 3 yrs of relevant experience** For PharmD, a one-year residency of fellowship can be considered as relevant experience.
• Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
• Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.

Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required)

• Fluent in English for written and verbally communication
• Ability to present and share useful business information across departments and functions.
• Knowledge of medical and drug terminology.
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
• Knowledge of ICH Guidelines.
• Knowledge of Medical Device reporting desirable.
• Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
• Ability to work independently with minimal supervision.
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.

Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Pay Range: CAD 90,000-110,000/ 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. Application Deadline: 02/13/26 Learn more about our EEO & Accommodations request here.