Drug Safety Specialist III
نُشرت في :
18-11-2022
صاحب العمل نشط
هذا المنشور غير متاح الآن! ربما يكون قد تم شغل الوظيفة.
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيValid email field required
أرسل الوظائف
شارك هذه الوظيفة
أرسل لي وظائف مشابهة
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيValid email field required
أرسل الوظائف
الراتب الشهري
لم يكشف
لم يتم الكشف عن الراتب
نُشرت في :
18-11-2022
الوصف الوظيفي
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 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.
- 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
- 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
- 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
- As evident from the above, our minimum requirement for this position is a comprehensive understanding of:
- Up-to-date knowledge of US and international PV regulations and best practices
- Thinks globally and considers present and future impacts when making recommendations
- Experience with PV vendor and business partner oversight and contract/agreement management
- Strong negotiation and problem-solving skills
- Analytical skills and attention to detail
- Accountability takes ownership of deliverables
نوع التوظيف
دوام كامل
المهارات المطلوبة
الإبلاغ عن هذه الوظيفة
إخلاء المسؤولية: د.جوب هو مجرد منصة تربط بين الباحثين عن عمل وأصحاب العمل. ننصح المتقدمين بإجراء بحث مستقل خاص بهم في أوراق اعتماد صاحب العمل المحتمل.
نحن نحرص على ألا يتم طلب أي مدفوعات مالية من قبل عملائنا، وبالتالي فإننا ننصح بعدم مشاركة أي معلومات شخصية أو متعلقة بالحسابات المصرفية مع أي طرف ثالث. إذا كنت تشك في وقوع أي احتيال أو سوء تصرف، فيرجى التواصل معنا من خلال تعبئة النموذج الموجود على الصفحة اتصل بنا
