Job Description
Job Description
Job Description
TITLE: Drug Safety Operations Associate
LOCATION: Stamford, CT
DURATION: 12 months
Job Description:
- Position performs adverse event processing and submission 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 (if requested by Purdue)
- Identify adverse events, seriousness, and listed Ness / labeled Ness 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)
- Five (5+) years of experience in a pharmaceutical/biopharmaceutical company
- Three (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
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
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