Drug Safety Associate in Connecticut (Remote)
: Job Details :


Drug Safety Associate in Connecticut (Remote)

TriOptus LLC

Location: Stamford,CT, USA

Date: 2024-11-20T20:42:53Z

Job Description:
Position: Drug Safety Associate Location: Connecticut (Remote)Job Description:
  • Position performs adverse event processing responsibilities supporting the Case Management function within Drug Safety Operations.
Primary Responsibilities:
  • Perform case processing activities (triage, data entry, report distribution) as required
  • Assess, process, and data enter all AE case types to meet compliance requirements
  • Perform triage on all case types to determine prioritization
  • Identify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability
  • Select the appropriate as reported causality and company causality
  • Perform all appropriate coding using MedDRA, WHO-DRUG, and Company Product dictionaries.
  • Own case narrative - create narrative text as required for medical orientation
  • Determine follow-up requirements and request follow-up as appropriate (e-mail, phone call, letter, etc.) to request additional information
  • Perform CRO case QC activities, reconciliation etc as required.
  • Support ICSR submissions and transmissions as needed
  • Work on highest priority or assigned cases using Workflow Management System, or as directed
  • Participate in inspections and audits as identified, including interviews and provision of requested data
  • Meet KPIs/KQIs as designated by client and in compliance with company guidelines and policies
  • Assist in writing late ICSR related deviations and CAPAs, upon request
  • Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within client organization.
Education and Experience Requirements:
  • Bachelor's degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
  • Minimum 5 years of experience in a pharmaceutical/biopharmaceutical company
  • Minimum 3 years in Drug Safety Operations role;
  • Experience overseeing CRO teams of case processors preferred
  • US FDA pharmacovigilance inspection experience preferred
Necessary Knowledge, Skills, and Abilities:
  • Resource and workflow management (monitoring and assigning tasks)
  • Up-to-date knowledge of US and international PV regulations and best practices
  • MedDRA coding
  • Considers present and future impacts when making recommendations
  • Strong negotiation and problem-solving skills
  • Analytical skills and attention to detail
  • Accountability - takes ownership of deliverables
  • Possible relevant titles: Seasoned PV lead or QC Associate on a CRO team
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