Job Summary
- Company
- Celgene Corporation
- Location
- Summit, NJ 07901
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Years of Experience
- 2+ to 5 Years
- Education Level
- Bachelor's Degree
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- Drug Safety Spec.
Drug Safety Specialist
About the Job
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If you’d like to join a company where you can make a difference, please consider the Celgene family.
The Drug Safety Specialist is: A regional role based at Summit, NJ Reports (at a minimum) to: Snr Manager, Case Management Responsible for: •Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised
To manage safety data within Celgene’s central safety database covering both pre- and post-market activities
AE CASE MANAGEMENT Apply at www.celgene.com/careers/pharmaceutical-us-job-openings.aspx or visit our website to view all of our open positions at www.celgene.com. Receipt •Execute receipt of Drug Safety phone calls and complete telephone AE form •Create phone call communication logs in ARISg Triage •Support the triage of cases conducted by Snr Specialist as needed Assessment - Complex Case •Support the assessment of complex cases conducted by Snr Specialist as needed Assessment - Non-Complex Case •Execute QC on key fields of serious cases •Create key fields updates in ARISg based on QC, as needed •Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality) •Create auto-narrative as needed •Review & update auto-narrative as needed •Create draft company comments for serious cases •Develop event rankings •Create dechallenge / rechallange determinations •Develop follow-up needs for AE reports •Create auto-populated follow-up letters •Review and update generated follow-up letters as appropriate •Authorise (approve) non-serious cases (except cases of special interest) •Create major modifications following Medical Review Medical Review •Support the identification of corrections and creation of updates in ARISg following medical review PHARMACOVIGILANCE (APPROVED PRODUCTS) PSURs •Update AE reports within safety database to support line listings COMPLIANCE, STANDARDS, TRAINING & PROJECT MANAGEMENT Preparation for Regulatory Inspection •Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates INTERNAL Global SAFETY DEPARTMENT DEVELOPMENT •Participate in product meetings within the drug safety department • Qualifications •Minimum of B.S. or the equivalent combination of relevant education or professional experience •Current registered medical license preferred Experience •Two (2)+ years relevant clinical experience Knowledge •Clinical knowledge of therapeutic area patient populations and drug class •Computer and database skills preferred •Must have strong written and oral communications skills
Celgene Corporation is an equal opportunity employer.
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Contact Information
Celgene Corporation
86 Morris Avenue
Summit, NJ
