What are the responsibilities and job description for the Drug Safety Operations Associate position at Axelon?
Description :
Position performs adverse event processing and submission responsibilities supporting the Case Management function within Drug Safety Operations.
Contract Duration : 12 months
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 (if requested by Purdue)
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
Support ICSR submissions and transmissions as needed.
Perform CRO case QC activities, reconciliation etc as required.
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 Purdue 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 Purdue 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
Summary of Work :
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
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Drug Safety Operations Associate?
Sign up to receive alerts about other jobs on the Drug Safety Operations Associate career path by checking the boxes next to the positions that interest you.
