Deborah Hayes Email & Phone Number

Apex, Nc, Us

Managed, reviewed and assessed contractual documents for new software licenses which often require non-routine contract management.Interacted regularly with external customers and other global staff, including Sales, Technical Support, Legal, Finance and others to provide optimum account management.Established a framework for administering non-standard contracts to ensure compliance with contractual terms and conditions, company policies and customer expectations.Understands and assessed implications of proper revenue recognition, global intra-company allocations and other issues related to the management of assigned contracts.Prepared customer invoices, and maintained associated back-up documentation, in accordance with contractual terms and conditions.Updated and/or edited internal customer database to add new license observations, initiate media creation and coordinate special requirements and/or exceptions as needed.

Raleigh-Durham, North Carolina Area

•Develop an expert knowledge of Sponsor Specific required forms, SOPs and Safety Directive, as well as an understanding of Sponsor structure and groups therein. Periodic reviews of the Safety Charter to ensure issues or enhancements identified by Safety Operations are incorporated.• Function as a lead and resource for the Clinical Trail Portal for SUSAR distribution in all aspects there of including CTMS, access requirements and algorithms and system limitations. Also responsible for the daily management of incoming SUSARs and distribution to teams.• AdHoc involvement in the driving of CAPAs, attendance at internal calls and face to face client meetings, root cause analysis and cooperation between SO and LSIM in delivery of message to client, and proactive risk identification from an Safety Operations perspective.•Create and maintain global Sharepoint sites, ensuring all information is current, coordinating with leads to provide any missing information identified and ensuring all studies are accounted for.• Create and document instructions for new global processes, including the authoring and piloting of a completely electronic case processing procedure, and providing training to global teams with aim to standardize procedures globally.• Build a positive, collaborative team environment with Lifecycle safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations with appropriate allocation of resource.• Receipt, triage and processing of data from various sources on time and within budget, while maintaining high quality. Per functional Safety Specialist role: coding medical events, writing narratives, generating queries, performing quality review, assisting w/ reconciliation, driving case closure and ensuring reports are sent within deadline• Provide oversight leadership role and have a strong understanding of operational team on status, metrics, productivity and initiatives

Raleigh-Durham, North Carolina Area

Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of secondary review.• Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.• Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.• Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.• Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.• Mentor less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects.• Participate in team meetings and provide regular feedback to operations team manager and lifecycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes.

Responsible for processing both serious and nonserious adverse event cases for clinical trials and marketed products including: assessment of reports for serious criteria according to applicable SOP, ICH, and Federal Regulations; performance of data entry and narrative writing; preparation of case reports (MedWatch and CIOMS) for medical review; assessment of case reports for due diligence; assistance with database reconciliation; and, compliance with domestic and international regulatory requirements. Also responsible for drafting PSRs for submission to the FDA for multiple drugs, training new pharmacovigilance associates, and medical information coverage including answering product specific questions, assessing phone calls for adverse events, and processing product complaints.

Worked as part of a team to help to ensure compliance with Medicare regulations by insurance companies involved with Workman’s Compensation cases. Daily tasks included the following; determined Medicare status through the acquisition of FACT reports, assembled submission packages to send to the Center for Medicare and Medicaid Services (CMS), and reported injures to the Coordination of Benefits (COB) by giving accurate descriptions and/or ICD-9 codes. Also, sent requests to the Medicare Secondary Payer Recovery Call Center (MSPRC) for Conditional Payment Letters and Final Demands, followed up with CMS for submission results, and processed incoming mail.

Provide administrative support to the Post Approval Pharmacovigilance (PVG) division. Responsibilities include safety database entry, quality control, client confidentiality, report distribution, project file creation and maintenance, and document management. Train new safety administrators. Effectively communicate with project team members and client contacts.