[Remote] Pharmacovigilance Analyst
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