Associate II, Pharmacovigilance – Remote (US)
Job Summary
Worldwide Clinical Trials, a globally recognized mid-sized CRO, is seeking an Associate II, Pharmacovigilance for a fully remote position in the United States. This role offers the opportunity to engage in comprehensive drug safety and pharmacovigilance activities, contributing to the success of global clinical trials from first-in-human studies to regulatory approval. Ideal for PV professionals passionate about ensuring drug safety and regulatory compliance.
Key Responsibilities
Author Safety Management Plans (SMPs) for assigned clinical studies.
Review Serious Adverse Event (SAE) data for accuracy and completeness.
Perform data entry and tracking of incoming safety information in the safety database.
Generate queries for missing or unclear data; liaise with sites for resolution.
Quality Check (QC) SAE reports processed by other PV Associates.
Generate regulatory reports and perform required safety submissions.
Prepare and submit periodic safety reports as needed.
Stay updated on safety regulations and guidelines.
Attend internal and client meetings to ensure seamless project execution.
Required Skills & Qualifications
Bachelor’s degree in a science-related field, nursing, or equivalent qualification.
Minimum of 1 year of pharmacovigilance experience (clinical trial phase).
Knowledge of medical/scientific terminology and clinical assessment of adverse events.
Understanding of international pharmacovigilance regulations and safety reporting.
Proficiency in MS Office applications (Excel, Word, PowerPoint).
Strong organizational skills with attention to detail.
Excellent written and verbal communication abilities.
Positive, adaptable, and collaborative mindset to work in global teams.
Perks & Benefits
Competitive compensation package.
Fully remote work flexibility across the United States.
Inclusive, diverse, and supportive global work culture.
Opportunity to impact global clinical research and patient safety.
Access to professional development and training resources.
About Worldwide Clinical Trials
Worldwide Clinical Trials is a leading midsize Contract Research Organization (CRO) committed to delivering innovative, high-quality clinical research services across the life sciences sector. With over 3,500 experts globally, the company drives progress in drug development, enhancing patient outcomes worldwide.
Work Mode: Remote (United States)
Call to Action:
Ready to shape the future of global drug safety? Apply now and join Worldwide Clinical Trials’ mission to improve patient lives through innovative clinical research. Visit: Worldwide Careers
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