Primary responsibility is oversight of processing of adverse events and safety data to ensure compliance with worldwide regulatory requirements, as well as adherence to internal procedures and contractual requirements with business partners. Prior experience with AE case processing and MedDRA coding, vendor oversight and vendor relationships is required. Experience in Medical Review of ICSRs and previous mentoring/leadership experience is preferred. The Candidate must be able to demonstrate solid knowledge of global safety Pharmacovigilance regulations and ICH guidelines, strong attention to detail and the ability to meet deadlines. Excellent written and oral communication skills are a must. Proficiency with Microsoft office suite (eg: Word, Excel, PowerPoint) as well as Outlook and Sharepoint. Must be able to work independently in a fast-paced environment while prioritizing and managing multiple competing tasks and demands. Responsibilities: 30%: Case Processing Oversight:
Review case processing quality, coding, seriousness, listedness, causality assessments, narrative writing and overall consistency and provide quality improvement feedback. Monitor vendor timeliness to ensure compliance to company and global regulatory reporting requirements. Support and monitor the vendor's day-to-day activities and urgently address and/or escalate any issues. 20%: Reconciliation Oversight:
Review timeliness and accuracy of reconciliation activities and provide quality improvement feedback. Monitor vendor timeliness to ensure compliance to reconciliation SOP. When warranted, urgently address and/or escalate any issues. 20%: Literature Review Oversight/QC:
Perform QC of literature review performed by the vendor and provide quality improvement feedback. Monitor vendor timeliness to ensure compliance to reconciliation SOP. When warranted, urgently address and/or escalate any issues. 10%: Late Case Investigation:
Review late submitted cases and determine root cause. Prepare late case CAPA or request CAPA from vendor and review vendor response for accuracy; request clarification and additional details from vendor when necessary for complete reporting of late case reason(s). 10%: Deactivation Review:
Review of vendor case deactivation requests to ensure AE data is has been completed correctly, case merges are complete and correct and that the deactivation request is valid. Push valid requests for business approval or reject and communicate issues/request corrections from vendor. 10%: Special Projects:
Assist Safety Vendor Management team by participating in special projects including, but not limited to, training of vendor, UAT, review of metrics, QC of ad hoc vendor tasks and maintenance of Sharepoint materials. Education & Experience Requirements:
Key Skills & Competencies:
- Minimum: Bachelor's degree in scientific or healthcare field.
- Preferred: Healthcare Professional (eg: MD, BSN, RN, Pharm D, R Ph)
- A minimum of 5 years of relevant experience with the following demonstrable skills:
- Post-market and Clinical Trial case processing activities, including data entry, narrative writing, and assessment of reportability
- MedDRA coding expertise and review of coding consistency reports
- Leadership/SME roles that include training, mentorship and QC of junior staff or vendors
- Prior experience in Vendor Management (preferred)
- Medical Review of ICSR (preferred)
- Triage of safety data for ICSR creation
- Prior experience with Argus desired
- Excellent clinical and post-marketing adverse event assessment review/documentation skills
- Excellent interpersonal, communication, analytical and organizational skills
- Strong vendor/partner relationship experience and mentorship of internal and/or vendor staff
- Strong knowledge of global clinical safety and pharmacovigilance regulations
Other Job Components: Complexity and Problem Solving
- Strong knowledge of MedDRA terminology and coding practices
- Adept with safety databases including report generation and ad hoc querying
- Proficient in late case investigation/CAPA
- Strong attention to detail
- Demonstrated ability to work in a fast-paced environment and simultaneously manage multiple competing tasks and demands
- Demonstrated ability to work independently, take initiative and complete tasks to deadlines
Independently make decisions and provide guidance to case processors utilizing company procedures as guidance.
Able to identify issues or procedural gaps and escalate to management.
Comfortable making suggestions for enhancements/efficiencies of internal processes and written procedures/tools to ensure that they are suitable and conform to industry and company best practices.
Able to identify safety system configuration/performance issues based on knowledge of safety case processing and database functionality. Internal and External Contacts
Regularly interact with vendor and safety systems support teams regarding case-processing issues, database concerns and safety reports.
Able to work with internal and external customers, supporting and fostering relationships between groups.
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