Senior Associate, Pharmacovigilance

🕒 May 26

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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

• Author Safety Management Plan for assigned studies • Attend internal and client meetings as appropriate • 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 • 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 • Prepare and submit periodic safety reports as needed • Maintain knowledge and understanding of safety related regulations and guidelines • Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope • May assist with bid defences or other presentations • May mentor or train new PV staff • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in a science-related field, or nursing, or equivalent • Minimum of 5 years of pharmacovigilance experience (pre-approval clinical trials) • Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word) • Excellent written and verbal communication skills • 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 (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting) • Fluent in written and verbal English.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible working hours • Paid time off • Professional development opportunities