Pharmacovigilance Specialist

OVERVIEW

The Pharmacovigilance Specialized Project Manager collaborates with the PV 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. The specialist is also responsible for the day-to-day coordination and administrative support of TransPerfect’s literature monitoring projects. The role provides essential support to the broader Production team, helping to ensure that all client timelines and deliverables are met.

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/super