At-a-Glance:
Are you ready to build your career by joining a pharmaceutical company? If so, our client is hiring a Drug Safety Operations Associate!
What You’ll Do:
- Perform adverse event processing responsibilities supporting the Case Management function within Drug Safety Operations.
Primary Responsibilities:
- Perform case processing activities (triage, data entry, and 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).
- 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 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.
What You Bring:
- 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.
Position Type: Contract
Get in Touch:
We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Rishaw at (862) 895-5483 to learn more.
Who We Are:
Since 1986, Hired by Matrix, Inc. has improved our candidates' lives with exciting job opportunities that provide outstanding career advancement. Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days, and a 401k option with a company match after one year. Hired by Matrix is an Equal Opportunity Employer and proud to be certified as both a Woman-Owned Business Enterprise and a Woman-Owned Small Business.
Connect with us on LinkedIn today and learn more about how HbM can change your career: https://www.linkedin.com/company/hired-by-matrix-inc/
Check out our Career Center: https://www.hiredbymatrix.com/find-work/open-positions/
