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