Lead Patient Data Intake Specialist - Remote

Overview

This position supports Patient Data Intake (PDI) organization to achieve its mission of improving patient lives through consistent and accurate delivery of high quality, relevant, and timely adverse event, medical information and product quality management by providing effective oversight of external providers of Pharmacovigilance services for AbbVie.

In Short

• Conduct oversight of vendors for adverse event information and Pharmacovigilance safety reports.
• Ensure compliance with global regulations in collection and processing of adverse event information.
• Assist internal and external customers with product safety reports and medical information requests.
• Ensure vendor quality, compliance, and productivity standards are met.
• Participate in audits and inspections as needed.
• Support development and delivery of training materials.
• Ensure effective communication with customers and colleagues.
• Document adverse events, medical information, and product complaints.
• Implement strategies to enhance PDI excellence.
• Act as a subject matter expert in adverse event and medical inquiry.

Requirements

• Bachelor’s degree with related health sciences background. RN, BSN, BS, BS Pharm preferred.
• 2-4 years’ experience in clinical healthcare and pharmaceutical industry.
• Demonstrated ability to lead project work and manage processes.
• Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA).
• Strong attention to detail and problem-solving skills.
• Excellent verbal communication skills.
• Strong documentation skills.

Benefits

• Comprehensive package of benefits including paid time off.
• Medical/dental/vision insurance.
• 401(k) participation.
• Short-term incentive programs eligibility.