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.
Support PV inspections and audits as identified, including interviews and provision of requested data.
Monitor vendor KPIs/KQIs as designated by Purdue and in compliance with company guidelines and policies.
Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization.
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.
...tech employees competing with existing jobseekers. Entry level job seekers struggle to get responses to their applications... .... Currently, we are looking for entry-level software programmers, Java full stack developers, Python/Java developers, data analysts/data...
...Competitive salary KENTECH Consulting Inc. is an award-winning background technology screening company. We are the creators of... ...checking system of its kind, and ClarityIQ a high-tech/high-touch investigative case management system. MISSION We're on a mission...
...professional development. Summer Professional Development Institute. Qualifications # Bachelor's degree in secondary education and/or History related field of study. # Proficiency in content area applying for, and clear understanding of how to relate content to the real...
...About Seaton Senior Living Seaton Senior Living, part of the Discovery Senior Living family of companies, is a recognized industry leader in performance, innovation, and lifestyle personalization. As one of the nations leading senior living operators, Seaton Senior...
At Fluor, we are proud to design and build projects and careers. We are committed to fostering a welcoming and collaborative work environment... ...provides technical and administrative direction to strategic management and to the Project Controls Functional Leader. In addition,...