Worldwide Clinical Trials
1001 - 5000 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
Associate II, Pharmacovigilance
🕒 May 31
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Worldwide Clinical Trials
1001 - 5000 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
📋 Description
• Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions. • Serves as Lead PV Associate on moderate to large sized studies that are moderate to complex in scope of work with moderate support from senior staff. • Author Safety Management Plan for assigned studies • Attend and present at Investigator Meetings • Review incoming SAE data for completeness and accuracy • Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information • Perform QC of SAEs processed by other PV Associates • Generate regulatory reports and perform safety submissions as needed
🎯 Requirements
• Minimum of 3 years of pharmacovigilance experience (pre-approval clinical trials) • Bachelor’s degree in science related field, nursing or equivalent combination of relevant education and experience • Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word) • Excellent written and verbal communication skills • Ability to handle multiple competing priorities while adhering to applicable timelines • Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting) • Fluent in written and verbal English.
🏖️ Benefits
• Collaborative and inclusive work environment • Opportunities for professional development
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