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[Remote] Pharmacovigilance Analyst

Remote · USA Full-time New today

Note The job is a remote job and is open 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
  • 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
  • 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

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