Associate Safety Case Reviewer

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