Associate II, Patient Safety Solutions REMOTE based in the USA

Fortrea•Durham, NC

4d•$28 - $35•Remote

About The Position

Fortrea is currently seeking an Associate II (Patient Safety Solutions) to perform clinical trial and post approval adverse event case processing. This role requires strong clinical knowledge as well as an understanding of the US Healthcare system. This is a (non-exempt) full-time, home-based position in the USA that will require willingness to work flexible hours as needed to meet business needs. WHAT YOU WILL DO You will be responsible for assisting with 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). 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. You will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.

Requirements

Associate’s degree + 2 to 4 years of safety experience
Associate’s degree RN + 2 to 4 years of safety experience
BS/BA + 2 to 4 years of minimum safety experience
MS/MA + 2 to 4 years of safety experience
PharmD + 2 to 4 years safety experience
Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
Minimum of 2 years of pharmacovigilance (PV) work experience in US/Canada.
Advanced command of English language, including speaking, writing, and reading.
Strong attention to detail with a high degree of accuracy.
Ability to work independently with minimal supervision
Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products.

Nice To Haves

Proficient with the Argus safety database.

Responsibilities

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial. This includes, but is not limited to:
Triage of incoming cases to prioritize for daily workflow management.
Perform duplicate checks and single case creation/initiation in the Oracle Argus safety database.
Perform validity, seriousness, expectedness/labeledness/listedness and determine causality using the WHO -UMC system.
Perform medical adjudication of incoming cases for the event seriousness in coordination with the medical review team.
Data entry and writing safety narratives of safety data into adverse event database(s) and tracking systems.
Review and coding of adverse events using MedDRA for completeness, accuracy and appropriateness for expedited reporting.
Identify clinically significant information missing from the reports and ensure its collection.
Perform urgent telephone queries to the reporter/HCP to clarify the missing or incomplete information.
Identify any discrepancies in the reports and send the appropriate queries to the vendors and the partners for further resolution.
Support Root cause analysis and CAPA plan development for identified quality issues, as needed.
Support and/or participate in audits and inspections, as needed.
Demonstrate role-specific Core Competencies and company values on a consistent basis ¨ Build and maintain good PSS relationships across functional units.
All other duties as needed or assigned.