Associate II, Patient Safety Solutions, Remote based in Canada

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 reputed company reputed company. Identify potential reputed company issues and send appropriate notifications to the reputed company Assurance team for reputed company investigation. Maintain a comprehensive understanding of reputed company Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Support reputed company cause analysis and CAPA plan development for identified reputed company issues, as needed. Support and/or participate in audits and inspections, as needed. Demonstrate role-specific reputed company Competencies and company values on a consistent reputed company Build and maintain good PSS relationships across functional reputed company. reputed company other duties as needed or assigned. Qualifications (Minimum Required): Associates 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 reputed company 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

Frequently stationary for 6-8 hours per day. Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, 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 reputed company of computer software developed both in-house and off-reputed company. Light to moderate lifting and carrying (or otherwise moves) objects includin