Litigation Associate handling civil, estate, and real estate disputes for Ottawa law firm Merovitz Potechin LLP. Advising clients within an experienced litigation team.
About the role
- Remote Associate II in Patient Safety Solutions at Fortrea managing clinical trial adverse events reporting and processing. Requires strong clinical knowledge and understanding of the US Healthcare system.
Responsibilities
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
- Triage of incoming cases to prioritize for daily workflow management.
- Perform medical adjudication for event validity/seriousness/expectedness/listedness/causality using the WHO-UMC system in coordination with the medical review team.
- Data entry of safety data onto adverse event database(s) and tracking systems.
- Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.
- Write patient narratives, code adverse events accurately using MedDRA and determine listedness against appropriate label.
- Identify clinically significant information missing from the reports and ensure its collection and follow-up.
- Ensure all cases that requiring expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines.
- 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.
- Undertake any other duties as needed.
Requirements
- 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.
- Minimum of two years of pharmacovigilance (PV) work experience in Canada / US
- Advanced command of English language, including speaking, writing, and reading.
- Proven expertise in processing U.S. post-approval cases is mandatory
- Proficient with the Argus safety database.
- Strong typing ability and familiarity with Microsoft Office Suite and Windows environment is advantageous.
- 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.
Benefits
- All job offers will be based on a candidate’s skills and prior relevant experience
- Applicable degrees/certifications
- Internal equity and market data
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