Nelissa Stashko, RN, MS

Experience

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  Abbott

  Aug 2001 - May 2007

  Sr. Clinical Safety Analyst

  • Utilized clinical knowledge to investigate, analyze, evaluate and case process reports of serious adverse events from clinical studies according to Abbott conventions, ICH and FDA guidelines to meet global regulatory reporting requirements (Canada, EU, Japan). • Successfully trained and mentored new colleagues. • Key leadership role as a liaison for metabolic study drug. • Led meetings with global project teams, solutions in process improvement and implementation in SAE reporting and SAE reconciliation.• Contributed as subject matter expert to consultants on special projects (E2B submission, SOPs, AEGIS, ARISg, and MedDRA). Show less

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  Medicis

  Dec 2007 - Dec 2012

  Clinical Safety Manager

  • Led Clinical Research team in establishing Adverse Event reporting processes on both drugs and devices from multiple studies and training on Safety reporting.• Collaborated successfully with regulatory submission team on multiple projects including luliconazole program, Restylane L aesthetics, and Dysport resulting in FDA approval. • Case processing of SAEs from clinical studies including triaging, reviewing, data entry of incoming reports from sites. • Reviewed and approved safety sections in clinical summary reports, protocols, IBs, Safety Exchange Agreement, annual reports, and other regulatory documents for NDA, BLA submission.• Key leadership role in evaluation and analysis of adverse events for expedited and periodic reporting.• Presented and provided training at investigator meetings and external vendors (CROs, CRAs, clinical research sites) on AE/SAE reporting. • Authored SOPs on expedited safety reporting of clinical trial SAEs (Drugs/Devices) including flowcharts specific to company products. • Oversight of clinical study specific AE/SAE reconciliation and safety data management with CROs and creation of AE Case Report forms (CRFs). • Created company guidelines in MedDRA/WHO drug coding for CROs specific to study drugs and devices from start to completion of clinical studies. • Assessed, reviewed, identified, and resolved deficiencies safety queries in study listings prior to database lock under tight timelines. • Provided clinical safety expertise in discussions, review, interpretation and approval of safety sections in clinical study documents (CSR, SAP, ISS, ISE) for regulatory submission and in preparation for annual safety reports on drugs and devices. Show less

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  Merz Aesthetics

  Aug 2013 - Mar 2014

  Sr. Drug Safety Scientist

  • Case processed, reviewed, and analyzed AEs and SAEs from post-marketing sources and clinical studies.• Improved efficiency and use of new ARISg (OnDemand) to optimal function in case processing routine and expedited cases, and periodic safety reporting.• Provided training to Drug Safety staff in case processing on ARISg database. • Harmonized and improved AE collection processes with third party vendors (CROs),new acquisitions, and global affiliates on all Merz products including drugs and devices. Show less

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  IQVIA (Formerly Quintiles)

  Apr 2015 - Nov 2017

  Sr. Clinical Safety Specialist

  I worked as a contract Sr. Clinical Safety Specialist intermittently from 2015- 2017 in PV Department at Quintiles. My responsibilities included: Triaged, reviewed, and timely processed up to 12 post marketing cases daily from various sources, within budget while meeting quality standards. Performed data entry for tracking and safety database, coding, and writing narratives. Generated and resolved queries pertinent to each case. Performed quality control, SAE reconciliation, timely metrics reports for Sponsors.Communicated with sites regularly on query resolution. Ensured compliance to Quintiles high quality standards in a matrix framework to achieve project and customer deliverables and execute administrative operational tasks as required. Show less

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  NantBio

  Mar 2018 - Oct 2018

  Sr. Pharmacovigilance Specialist

  • Performed SAE case processing including SUSARs in compliance with Global Safety• reporting requirements.• Served as the Pharmacovigilance (PVG) representative for study teams. • Managed clinical study project set-up/close-out, regulatory reporting. • Assisted in the preparation of periodic reports and any ad hoc reports as necessary. • Ensured the quality of the SAE database and QC of cases entered by PVG staff. • Coordinated activities to address safety issues for global and domestic clinical studies, and direct PVG team efforts for any safety review committee (SRC) and Drug Safety Monitoring Board (DSMB) activities. Show less

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  Advanced Clinical

  Oct 2018 - Nov 2022

  Pharmacovigilance Specialist

  • Led global safety reporting on SAEs from clinical studies, SAE reconciliation, narratives, and Safety database system design and maintenance• Collaborated closely with Medical Monitor to review ICSRs to determine reportability for potential SUSAR. Periodic review and analysis of SAE listings, tables and metrics• Wrote narratives for individual ICSRs and safety sections in periodic update safety reporting (PSUR), CSR, Annual IND Safety reports, and other Aggregate reports• Led ARISg safety database from validation to implementation projects on global electronic submissions including Webtrader set up with FDA, Safety database audits, and provision of ARISg user training• Created ICSR scenarios (SUSAR and regular cases from both post marketing and Clinical studies. i. e. literature, Parent/child, initial, follow up etc. for Global Regulatory Agencies for approval on electronic submissions E2B-ESM• Liaised with global regulatory agencies FDA, Health Canada, and EMA during validation approval process, database upgrades, Regulatory requirement updates for E2B submission compliance. Successfully gained approval from FDA, EMA and Health Canada on electronic submissions• Developed and wrote SMPs for multiple clinical trials/PV SOPs, and implementation of departmental processes and guidelines. Trained CRAs, PM and other clinical study members on Safety processes• Oversight on Safety startup activities to database lock on multiple clinical studies on various therapeutic areas: oncology, metabolic, dermatology, medical devices, infection disease, dermal fillers, rare genetic diseases. Designed and created eCRFs for EDC and SAE templates and Forms• Represented PV in bid defenses, PV audits. Conducted training and presentations at KOMs, IMs, client meetings, and to internal employees• Provided expertise in PV to Sponsors to meet study budgets• Led safety meetings with functional teams and provide directions to investigative sites on SAE reporting Show less

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  Cytokinetics

  Nov 2022 - Mar 2023

  Drug Safety Case Manager (Contract)

  • Ensured that all safety reports received from any source for Cytokinetics’ products are processed in the safety database and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs, Work Instructions, departmental procedures, and business partner agreements• Oversight of CRO processing SAE reports on Cytokinetics products in accordance with all applicable regulations, guidelines, and SOPs. This includes detailed review of source documentation, assessing cases for reportability, generation of analysis of similar events, quality check• Processes adverse event related information in drug safety database for Cytokinetics’ products, including the writing of narratives for expedited and non-expedited reports• Participated in Study Operation Team meetings for assigned studies and leads the PV-related study activities including preparation of study start-up activities (e.g., development of study-specific Safety Management Plans, training of internal /external project-team members in safety-reporting processes, development of safety report forms, safety data reconciliation, site initiation training activities)• Liaised with other functional groups for implementation of PV-related processes requiring cross functional collaboration, such as SAE data reconciliation between Clinical and Safety databases Show less

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  Deciphera Pharmaceuticals

  Jul 2023 - Mar 2024

  Manager, PV Operations

  • Provide oversight of the PV operational and case management activities for safety reporting including the collection, processing, and reporting/submission of safety information for all Deciphera products (investigational and commercial) including the review and monitoring of case quality and compliance through various monitoring reports and other oversight activities • Lead PV vendor management oversight activities including day-to-day oversight, review, and evaluation of the vendor performance and quality• Collaborate with study team members to develop documents related to safety case processing and reporting such as Safety Management Plan, Safety Reporting Forms and completion guidelines, reconciliation plan, data handling conventions, Lead SAE reconciliation • Collaborate with internal teams to prepare for Regulatory Authority inspections and in relevant internal/external audits as subject matter expert on Pharmacovigilance operations • Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and PV agreements with partners, vendors, and other third parties Show less

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  Innoviva Specialty Therapeutics, Inc.

  Feb 2024 - May 2024

  Pharmacovigilance Operations Lead (Consultant)
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  Fusion Pharmaceuticals

  May 2024 - now

  Senior Manager, Global Safety & Pharmacovigilance