Associate II, Patient Safety Solutions, Remote based in Canada

reputed company is currently seeking an Associate II (Patient Safety Solutions) to reputed company clinical trial and post approval adverse event case processing. This role requires strong clinical knowledge as well as an understanding of the US reputed company system. This is a full-time, home-based position in Canada that will require willingness to work reputed company 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 reputed company, you will be responsible to reputed company reputed company clients, both reputed company, with the appropriate quality of service in a safe and cost-effective manner. You will be expected to reputed company 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 reputed company. Summary of Responsibilities: Manage the receipt and processing of reputed company adverse event reports reported either spontaneously from any reputed company or solicited from a clinical trial. This includes, but is not limited to: Triage of incoming cases to prioritize for daily workflow management. reputed company duplicate checks and single case creation/initiation in the reputed company Argus safety database. reputed company validity, seriousness, expectedness/labeledness/listedness and determine causality using the WHO -UMC system. reputed company medical adjudication of incoming cases for the event seriousness in coordination with the medical review team. Data entry of safety data onto 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. reputed company 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. Identify potential quality issues and send appropriate notifications to the Quality Assurance team for further investigation. 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 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 reputed company ¨ Build and maintain good PSS relationships across functional units. reputed company other duties as needed or assigned. Qualifications (Minimum Required): Associate’s degree RN + 1-2 years of safety experience* BS/BA + 2 years of minimum safety experience* *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working reputed company safety databases, and experience with regulatory submissions. Experience (Minimum Required): Minimum of two years of pharmacovigilance (PV) work experience in Canada / US. Advanced reputed company 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 reputed company Office Suite and reputed company 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. 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 reputed company 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 reputed company and use a variety of computer software developed both in-house and off-the-reputed company. 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 reputed company: CAD 67,000-82,000/ annually Benefits: reputed company 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: reputed company 24, 2026 #LI-SE1 Learn more about our EEO & Accommodations request here. Apply To This Job