Associate II – Patient Safety Solutions

This is a fully remote position, open to applicants in Canada.

📋 Description

• Assist in the operations of Clinical Safety and/or Patient Safety Solutions for both clinical-trial and post-approval products.

• Oversee the receipt and processing of spontaneous and clinical-trial adverse-event reports.

• Triage incoming cases and prioritize the daily workflow effectively.

• Conduct medical adjudication to assess event validity, seriousness, expectedness, listedness, and causality using the WHO-UMC system.

• Input safety data into adverse-event databases and tracking systems.

• Review adverse events to ensure completeness, accuracy, appropriateness, and compliance with expedited-reporting requirements.

• Compose patient narratives and code adverse events utilizing MedDRA.

• Verify listedness against the relevant product label.

• Identify any missing clinically significant information and follow up accordingly.

• Manage cases that necessitate expedited reporting to global regulatory authorities within stipulated timelines.

• Maintain a thorough understanding of SOPs, work instructions, guidance documents, and pharmacovigilance directives.

• Assist in root-cause analysis and the development and implementation of CAPA.

• Support or take part in audits and inspections as required.

• Establish and sustain relationships across functional units for Patient Safety Solutions.

• Perform additional duties as necessary.

⛳️ Requirements

• Associate’s degree OR RN with 2 years of Safety experience OR BS/BA with 1 year of Safety experience OR MS/MA with 1 year of Safety experience OR PharmD with 1 year of Safety experience.

• Relevant and equivalent experience may be accepted in lieu of educational qualifications.

• A minimum of two years of pharmacovigilance (PV) experience in Canada or the US.

• Advanced proficiency in English, including speaking, writing, and reading.

• Demonstrated experience in processing U.S. post-approval cases.

• Proficient in using the Argus safety database.

• Strong typing skills.

• Familiarity with Microsoft Office Suite and Windows environment is advantageous.

• Exceptional attention to detail and a high level of accuracy.

• Ability to work independently with minimal supervision.

• Good understanding of ICH guidelines and global regulatory requirements regarding adverse-event reporting.

• Willingness to work flexible or varied hours as necessary.

• Consistent and regular attendance is required.

• Capability to use both in-house and commercially available software.

• Ability to meet physical requirements including sitting for 6–8 hours, repetitive hand movements, occasional travel, and lifting 15–20 lbs.

🏝️ Benefits

• Full-time, home-based position.

• Flexible hours as required to accommodate business needs.

• Compensation is based on skills, relevant prior experience, degrees/certifications, internal equity, and market data.

• EEO & accommodations support available.