[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
ā¢ Management of safety cases and reports from all sources, including case intake/triage, data entry, quality review, medical review, and follow up activities
ā¢ Electronic documentation and filing of safety information according to SOPs and safety management processes
ā¢ MedDRA coding of data in the safety database
ā¢ Preparation of case narratives
ā¢ Reconciliation of the clinical and safety databases
ā¢ Provide support for regulatory submission preparation and review
ā¢ Coordinate safety project setup, including safety database build
ā¢ Author sponsor/project specific safety management plans
ā¢ Conduct and assess literature searches
ā¢ Participate in sponsor/investigator meetings as required
ā¢ Maintain a working knowledge of the safety database
ā¢ Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation
ā¢ Perform other duties as assigned
Skills
ā¢ Pharmacovigilance knowledge and experience including safety case processing for clinical trials (drugs, biologics, vaccines, and medical devices)
ā¢ Proficient in MS Office and Adobe Acrobat
ā¢ Good Understanding of MedDRA & WHODrug Global dictionaries
ā¢ Must display analytical and clinical skills
ā¢ Requires narrative writing skills
ā¢ Degree in Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
ā¢ Nursing experience is a plus
Company Overview
ā¢ 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
ā¢ 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.
Responsibilities
ā¢ Management of safety cases and reports from all sources, including case intake/triage, data entry, quality review, medical review, and follow up activities
ā¢ Electronic documentation and filing of safety information according to SOPs and safety management processes
ā¢ MedDRA coding of data in the safety database
ā¢ Preparation of case narratives
ā¢ Reconciliation of the clinical and safety databases
ā¢ Provide support for regulatory submission preparation and review
ā¢ Coordinate safety project setup, including safety database build
ā¢ Author sponsor/project specific safety management plans
ā¢ Conduct and assess literature searches
ā¢ Participate in sponsor/investigator meetings as required
ā¢ Maintain a working knowledge of the safety database
ā¢ Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation
ā¢ Perform other duties as assigned
Skills
ā¢ Pharmacovigilance knowledge and experience including safety case processing for clinical trials (drugs, biologics, vaccines, and medical devices)
ā¢ Proficient in MS Office and Adobe Acrobat
ā¢ Good Understanding of MedDRA & WHODrug Global dictionaries
ā¢ Must display analytical and clinical skills
ā¢ Requires narrative writing skills
ā¢ Degree in Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
ā¢ Nursing experience is a plus
Company Overview
ā¢ 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
ā¢ 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.