Specialist I Pss

2 weeks ago

Toronto, Canada Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Specialist I, Patient Safety Solutions

This is a remote, home based role, located in Canada.

Job Overview:
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:
- Data entry of safety data onto adverse event database(s) and tracking systems- Write patient narratives and code adverse events accurately using MedDRA- Perform Database reconciliation with Data Management team or sponsor/client as needed

Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), including but not limited to:
- Set-up and maintenance of project files and central files for documentation- Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines- Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc.- Contribute to root cause analysis, including the CAPA plan development & implementation- Support Audits and/or inspections preparation

Job

**Required Skills**:
- Non-degree + 2 years of Safety experience
- or 4-5 years of relevant experience**- Associate Degree + 2 years of Safety experience
- or 3-4 years of relevant experience**- BS/BA + 1-2 years of Safety experience
- or 2-3 years of relevant experience**- MS/MA + 1-2 years of Safety experience
- or 2 years of relevant experience**- PharmD + 1-2 years of Safety experience
- or 2 years of relevant experience**

For PharmD, a one year residency of fellowship can be considered relevant experience.

Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
- 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, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

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