Note: The job is a remote job and is open to candidates in USA. Prevail InfoWorks is a company specializing in eClinical technology products, focusing on delivering innovative solutions for clinical data integration and risk-based data analytics. The Pharmacovigilance Analyst II will support pharmacovigilance and medical monitoring activities, ensuring compliance with global regulations and SOPs while managing safety cases and reports.

Responsibilities

• Management of safety cases and reports from all sources, including case intake/triage, data entry, quality review, medical review, and follow up activities
• Electronic documentation and filing of safety information according to SOPs and safety management processes
• MedDRA coding of data in the safety database
• Preparation of case narratives
• Reconciliation of the clinical and safety databases
• Provide support for regulatory submission preparation and review
• Coordinate safety project setup, including safety database build
• Author sponsor/project specific safety management plans
• Conduct and assess literature searches
• Participate in sponsor/investigator meetings as required
• Maintain a working knowledge of the safety database
• Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation
• Perform other duties as assigned Skills
• Pharmacovigilance knowledge and experience including safety case processing for clinical trials (drugs, biologics, vaccines, and medical devices)
• Proficient in MS Office and Adobe Acrobat
• Good Understanding of MedDRA & WHODrug Global dictionaries
• Must display analytical and clinical skills
• Requires narrative writing skills
• Degree in Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
• Nursing experience is a plus Company Overview
• Prevail InfoWorks is a system integration and analytics software company. It was founded in 2005, and is headquartered in Philadelphia, Pennsylvania, USA, with a workforce of 51-200 employees. Its website is Company H1B Sponsorship
• Prevail InfoWorks has a track record of offering H1B sponsorships, with 1 in 2024, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role. Apply To this Job