Job Description
Job Description
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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