OVERVIEW
The Associate Safety Case Reviewer collaborates with the Pharmacovigilance Solutions Production team to analyze and report on safety parameters within the context of patient safety against our clients’ products, and in line with client requirements for case review.
DESCRIPTION
Perform various tasks in support of our clients’ clinical research including: adverse event analysis and processing
Prepare safety reports for submission to various health authorities
Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards
Adhere to project timelines, with proactive communication with Team Lead and Project Managers, as needed
Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and Standard Operating Procedures (SOPs)
Analyze stakeholder complaints related to safety reporting, address in real time, and discuss with Project Managers to mitigate risk and implement/drive solutions
Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor
REQUIRED SKILLS
Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding
Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and International Conference on Harmonization (ICH) guidelines
Proficiency in Word, PowerPoint, Excel, Outlook, EndNote, and scientific databases including PubMed, Embase, etc.
Excellent written and oral communication skills in English
Ability to work in collaborative, cross-functional teams
Ability to meticulously review and validate work to ensure strict compliance with SOPs and client specifications