Pharmacovigilance Specialist

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $50k - $99k / year

⏰ Full Time

🟢 Junior

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

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 • Author Safety Management Plan for assigned studies • Review incoming SAE data for completeness and accuracy • Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information • Generate queries for missing or unclear information and follow-up with sites for resolution • Perform QC of SAEs processed by other PV Associates • Generate regulatory reports and perform safety submissions as needed

🎯 Requirements

• Bachelor's degree in a science-related field, nursing, or equivalent • Minimum of 1 year of pharmacovigilance experience (pre-approval clinical trials) • 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 • Excellent organization skills and attention to detail • Ability to handle multiple competing priorities while adhering to applicable timelines • Ability to work independently, prioritize work effectively and work successfully in matrix team environment • Ability and willingness for potential limited travel (domestic and international) as needed

🏖️ Benefits

• Competitive benefits package depending on location • Pay equity and transparency