[Remote] Pharmacovigilance Analyst

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company 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
• reputed company 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
• reputed company 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 reputed company 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-reputed company field, or equivalent qualification/work experience
• Nursing experience is a plus Company Overview
• reputed company 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
• reputed company 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 tot his job Apply To this Job

Apply tot his job Apply To this Job Apply tot his job Apply To this Job