DRUG SAFETY - Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycle; Participate in the set-up and maintenance of adverse event processes in global clinical trials; Perform Quality Review of the Individual Case Safety Report, including data and a concise, medically relevant narrative. Monitor the Drug Safety Mailbox for SAE reports; Query Management; Author clinical safety narratives for the CSR; Provide oversight for the TMF (Safety specific). SIGNAL DETECTION - Identify potential signals and escalate to the medical review function; Gather and analyze safety data for escalation to the Executive Safety Advisory Committee; Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures.AGGREGATE REPORTS - Contribute to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, DSUR and CSR.OTHER - Attend Project Team meetings for assigned studies; Obtain clinically meaningful information from investigators to provide a robust safety assessment; Create and/or contribute to SOP development, Job Aids and documents; Develop electronic case report forms, configure the Clinical database for Safety specifications, perform User Acceptance Testing, maintain documentation, and perform reconciliation with the clinical trial data; Act as a liaison internally and externally (e.g., Clinical Development, Regulatory Affairs, Biometrics, parent company and business partners) to develop programs and processes.

• Responsible for data entry, and querying, of serious adverse event (SAE) reports into Argus Safety Database• Perform other relevant tasks and projects, including (but not limited to) participation in SAE reconciliation, team meetings, and filing of submission documentation.• Ensure prompt and accurate processing of adverse event data.• Provide accurate individual case reports for submission to regulatory authorities and participating clinical trial investigators in compliance with the regulatory time frames for reporting.• Serves as member of project teams. Communicate timelines, provide deliverables and inform the project team on the status of activities and issues.• Revise and maintain processes and procedures for drug safety in compliance with regulatory requirements and company standards. • Maintain knowledge of regulatory requirements.• Prepare Safety sections of summary reports, including IND Annual Reports, and DSURs.• Review, revise and approve Safety Management Plans

• Provide clinical and safety data assessment of reports from post marketing events involving Integra LifeSciences products• Coordinate assessment and documentation associated with adverse reactions, product technical complaints and/or serious individual adverse events leading to a medical device report• Provide responses (phone, written or email) for medical inquiries from consumers and HCPs• Develop ongoing documents in response repository and review to identify emerging trends• Provide cross-functional medical support to Integra’s family of companies• Identify clinically significant information missing from initial reports and ensures its collection• Ensure case receives appropriate regulatory / medical review• Contribute to the development and maintenance of standard and custom product information responses• Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines

- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. - entry of safety data onto adverse event database(s) and tracking systems- review of adverse events for completeness, accuracy and appropriateness for expedited reporting- write patient narratives- code adverse events accurately using MedDRA- determine expectedness/listedness against appropriate label- identifies clinically significant information missing from initial reports and ensures its collection- ensure case receives appropriate medical review- prepare follow-up correspondence consulting the medical staff accordingly.- ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines- reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines- provide independent QC of AE reports for other members of the group- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.- Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.- Actively participates in project team and client meetings and liaise with clients, where appropriate.

• Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance• Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements• Prepare safety data reports for submissions to clients• Prepare and/or review Expedited Safety Reports for submission to Regulatory Authorities• Communicate with Clinical Operations and clients to ensure compliance with safety and pharmacovigilance SOPs• Assist with preparation of regulatory submissions reports, i.e., Annual Reports, Periodic Safety Update Reports• Function as the safety lead for assigned projects; to include set-up, project management, client liaison• Prepare Safety Management Plans• Mentor / Train other Safety Associates and other members of the Global Safety and Pharmacovigilance group involved in safety data processing • Perform all reconciliation activity for a study• Maintain current knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and pharmacovigilance reporting

• Under direct supervision, designed, planned, developed, and monitored all phases of clinical trials• Assisted with writing, editing, amending, and reviewing clinical trial documents, including protocol, sample ICF or operations manuals (e.g. monitoring plans, CRF completion guidelines, etc)• Site management of clinical sites including training, protocol adherence and general correspondence• Performed pre-study evaluation, site initiation, routine monitoring and close out visits to ensure compliance with the study protocol• Developed and reviewed visit reports for completeness and accuracy• Monitored clinical sites in accordance with all applicable guidelines and regulations• Independently identified and communicated findings to site coordinator, study PI, sponsor medical monitor and study manager, as appropriate• Assured correct shipping, storage, inventory, reconciliation and resolved any discrepancies both in-house and at site of investigational product• Collected, evaluated, communicated and tracked essential regulatory documents• Reviewed and evaluated budgets submitted by the clinical sites, tracked and initiated investigator payments• Reviewed and analyzed data reports for content and assimilated comments for internal team and/or vendor• Implemented detailed action plans based on general direction from manager and study team• Facilitated a timely and accurate communication flow with site personnel• Ensured compliance with all federal, state, local and company regulations, policies and procedures for Health, Safety and Environmental compliance

Conducted health screenings (B/P, Blood sugar, Osteoporosis, Skin Cancer, etc) for Middlesex county residentsSupported, counseled and educated patients and community as necessary

Served as staff nurse, preceptor and charge nurse on NICU, Medical-Surgical Unit and Transtional Care Unit