Drug Safety Operations Associate

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