Drug Safety Drug Safety Associate III - Remote Stamford, Connecticut

Orbis Clinical is seeking a remote-based Drug Safety Associate III for 12 months.

Job Title: Drug Safety Associate III

Location: Fully remote and onsite required during Inspections

Contract: 12 months

Job Description  

Position performs adverse event processing responsibilities supporting the Case Management function within Drug Safety Operations.  

• 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 company) 
  • Identify adverse events, seriousness, and listedness/labeledness for case assessment; review additional incoming information to determine reportability. 
  • Perform all appropriate coding reviews 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 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 company 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 company organization. 
• Prepare monthly QC metrics and distribute among the team. 
• Active Participation in Inspection readiness work and respond to FDA queries. 
• Perform vendor management activities like coordinating with vendors on ICSR QC activities and voice call QC activities as needed.

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 

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $32.25 – $34.48 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.