TransPerfect is a leading global provider of language and technology solutions for businesses worldwide. With a commitment to innovation and excellence, TransPerfect offers a range of services, including translations, e-learning, legal support, and clinical research solutions. This role as a Pharmacovigilance Specialist is an exciting opportunity to contribute to the critical area of patient safety within a dynamic and innovative organization.
Responsibilities in the Job
As a Pharmacovigilance Specialist at TransPerfect, you will:
- Analyze Adverse Events: Collaborate with the Lit Search/Medical Writing team to analyze and process adverse event reports.
- Prepare Safety Reports: Compile and submit safety documents to health authorities across various regions.
- Ensure Compliance: Maintain data integrity through adherence to Good Documentation Practice (GDP) and other compliance standards.
- Data Analysis: Conduct safety document reviews and data analysis to provide actionable insights.
- Timely Communication: Maintain proactive communication with project managers and clients to ensure adherence to timelines.
- Process Improvements: Recommend and implement operational enhancements within the department.
- Stakeholder Interaction: Address and resolve stakeholder complaints related to safety reporting in real time.
- Adapt to Industry Changes: Stay updated on changes in the healthcare landscape to anticipate potential impacts on clients and projects.
Qualifications
Candidates for this position should meet the following qualifications:
- Educational Background: Doctor of Pharmacy (PharmD) or Doctor of Medicine (MD) from an accredited institution.
- Experience: Minimum of 2-3 years in drug safety or pharmacovigilance.
- Knowledge: Familiarity with Good Clinical Practice (GCP), GDP, International Conference on Harmonization (ICH) guidelines, and medical terminology.
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