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