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/supervisor Oversee administrative aspects of non-linguistic Pharmacovigilance projects, including but not limited to file transfers, internal process checks and balances, and client deliverables Monitor and communicate project progress, ensuring strict adherence to timelines and the delivery of high-quality outputs Collaborate with senior team members to support smooth and timely client deliveries 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 Strong attention to detail and adherence to SOPs and client specifications Ability to learn and adapt to new technologies and systems Good problem-solving and critical thinking skills Solid organizational and time-management skill REQUIRED EXPERIENCE AND QUALIFICATIONS Minimum Bachelor degree or its equivalent Experience in working with collaborative, cross-functional teams Medical experience and minimum 1-year Pharmacovigilance experience Doctor of Pharmacy (Pharm D), Bachelor in Life Sciences DESIRED SKILLS AND EXPERIENCE Drug development/clinical trial experience Creative thinker – Curious and unafraid to ask questions Hard worker – Industrious and diligent in everything you do Innovator – Willing to initiate changes and introduce new ideas