SUMMARY:

• Confidential has 12+ years of hands - on experience in Global Pharmacovigilance, Drug Safety, Risk Management, Signal Detection and Safety Systems, Oncology, Global Medical Affairs, Medical and Narrative Writing, Clinical Studies.
• Exceptionally strong clinical and pharmaceutical knowledge base/background.
• Extensively working with PVR support team to develop and test global queries, templates and reports in PV Reports
• Expertise in Clinical responsibilities include quality medical review of clinical cases and ability to draft and/or review the safety sections of clinical documents in preparation for a clinical trial.
• Active participation in the slide development for Advisory Committee and Confidential approval.
• Hands on project management experience in circulating reports for team review and quality control/quality assurance.
• Expertise in Clinical Study Protocols and submission components such as Summary of Clinical Safety (SCS) and Summary of Clinical Efficacy (SCE).
• Serve as a SME in the redaction of aggregate reports and other regulatory reports in support of Freedom of Information (FOI) requests.
• Expertise in reconciliation of reviewers'/auditors' comments and resolving inconsistencies in a timely manner.
• Extensive hand-on experience with CRO/vendor oversight of pharmacovigilance deliverables and database implementation deliverables (i.e. IQVIA, Parexel, Covance, PRA Health Sciences, Pharmaceutical Product Development, Drug Safety Alliance, United BioSource, Foresight, Rxlogics).

SKILLS:

Proficiency in: Spanish and English

Programming Languages: C++, Perl, BioPerl, MySQL, JAVA, SQL, t-SQL

Webpage Application and Design: Linux/Unix, CGI, HTML, CSPro

Databases: Intercom Plus, Emergency Department Information Manager (EDIM), QUMAS DocCompliance, Argus Safety Database, GXPharma, Empirica Trace, ORION, WFRS

Relational Database Management: Microsoft SQL Server, Oracle SQL

Office Tools: MS Word, MS Power Point, MS Excel, MS Access, MS Outlook, MS Visio, MS Project

Biomedical Informatics tools for Protein Modeling: Modeller, 3D Verify, R, Chimera, JMol

PROFESSIONAL EXPERIENCE:

Confidential, Rahway, New Jersey

Sr. Aggregate Report Quality Specialist, Drug Safety SME

Responsibilities:

• Serve as a Subject Matter Expert (SME) trainer for the writing and management of aggregate reports.
• Serve as a SME in the redaction of aggregate reports and other regulatory reports in support of Freedom of Information (FOI) requests.
• Serve as a SME liaison for Pharmacovigilance Reporting Tool (PV Reports).
• Serve as a point of contact for aggregate team’s mailbox management, FDA inspection and internal/BP audits.
• Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV legislation.
• Responsible to hold PVR Open Sessions and workshops twice a week to help team members configure reports in PVR reporting tool.
• Prepare PVR agenda items, PVR meeting minutes and PVR communications.
• Assist in the troubleshooting and testing of PV Reports/Narrative writing for products with product exceptions and supplementary database outputs.
• Work with PVR support team to develop and test global queries, templates and reports in PV Reports.
• Develop, support and maintain processes to ensure high quality of aggregate reports (i.e. PVR SOPs, Execution Resources (ERs), QC Checklists, Job Aids and Step-by-Step Demos to assist in the generation of PVR outputs and management of aggregate reports) in accordance with PV policy and legislation.
• Participated in User Acceptance Testing (UAT) activities ranging from reviewing test scripts to conducting dry runs and Formal Execution Testing.
• SME for quality review of aggregate reports and source verification of data including database output and patient exposure.

Confidential

Senior Manager, Aggregate Reports Quality

Responsibilities:

• Prepare and manage EU Renewals, Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategy Plans (REMS) for investigational compounds in various stages of clinical development and marketed products using the timeframes d in the project plan.
• Circulate reports for team review and quality control/quality assurance.
• Reconcile the reviewers'/auditors' comments and resolving inconsistencies in a timely manner.
• Ensure that all deliverables are provided on the appropriate milestone dates.
• Work with project managers to ensure business partner information and literature searches are received on time.
• Prioritize work to ensure that critical path milestones are delivered on dates d in project plan.
• Ability to use ARGUS Safety Database to search for outstanding cases.
• Ensure IT output is consisting with previously submitted reports/Narrative writing by conducting quality checks and comparing of cumulative data across reporting periods.
• Navigate WFRS and FSA database to obtain Patient Exposure Data.
• Use ORION database to enter events as required.
• Use Aggregate Report Team (ART) SharePoint portal to post templates, previously submitted reports, upload email records, QC Checklist, IT Output Request Forms.
• Participate in ongoing process improvement initiatives.
• Participate and represent Aggregate Report Team in DSUR kick-off meetings.
• Maintain a strong people management and project management rapport.
• Assist in the of new members as new aggregate report projects are assigned.

Confidential, Ardsley, New York

Argus Safety Systems Analyst

Responsibilities:

• Develop Argus system for business users under direction of the head of Safety Systems.
• Train and/or facilitate of vendor’s systems for stakeholders of the Argus Implementation Team in preparation of bringing the database in-house (IT, QA, Medical Affairs, Project Management, Clinical, Regulatory Affairs, etc).
• Systems included case management, workflows, case routing, report generation and systems management and administration such as assigning systems privileges and permissions.
• Train internal and external staff on systems risk management assessment, Argus database documents, Change
• Control SOP, MedDRA upgrade SOP, WHODRUG SOP and other Argus Safety Systems documents.
• Ensure that all validation documentation needs are met to auditable standards. This includes validation plans, flow charts, system design specifications, business user requirements, functional requirement specifications, traceability matrix, risk assessments, IQ, PQ and OQ protocols and test scripts.
• Support the generation of complete and accurate periodic reports and ad-hoc reports/Narrative writing for various constituents with interest in the safety database i.e. Legal, Clinical and Risk Management.
• Participate in the establishment of Data Entry Guidelines to ensure consistent and accurate data entry.
• Assist in the configuration and validation of Safety System updates and upgrades.
• Assist with the testing, validation and execution of E2B .
• Maintains and adheres to Periodic Report schedule, creating aggregate submissions in submission ready standards (PSURs, PADERs, ASRs and DSURs).
• Contributes to the development of validated Post-marketing and Clinical Signal Detection Reports.
• Manage change controls, upgrades and backup/restore process.
• Documents the templated narratives in the Argus Safety Database System Configuration.
• Applies configuration and workflow setup to system.
• Write clear and concise narratives for ICSRs.
• Develops and executes test scripts to verify compliance to system configuration.
• Provides Argus Safety user support, user, and system administration.
• Develops Safety System materials and delivers to employees.
• Participates in the establishment of Data Entry Guidelines to ensure consistent and accurate data entry.
• Responsible for the quality control of all validation documents including responses to audit reports/narrative writing of validation documents including test scripts, business user requirements, functional requirements, protocols, risk assessments, etc.
• Responsible for the complete document management of the Oracle Argus implementation documents including drafting where appropriate, review cycle and tracking of validation documents.
• Assist with FDA inspections pertaining to the project management and other activities of the Oracle Argus implementation project and database validation.

Senior Risk Management Associate

Confidential

Responsibilities:

• Report to VP of DSRM and serve as Project Manager to represent Risk Management for all REMS programs and REMS documents.
• Conduct on all REMS documents and Supporting Risk Management documents.
• Conduct REMS for all stakeholders during FDA inspections and internal QA audits.
• Prepare and deliver REMS presentations for cross-functional internal teams and external staff.
• Participate in the drafting and review of REMS documents, scheduling meetings, consolidating team comments for REMS documents and REMS, drafting meeting minutes and meeting agenda.
• Responsible for the collection, storage and distribution of Key Events (internal risk management plan / tracker) to the Safety Committee.
• Assist the VP in structuring the Risk Management development by drafting various safety documents including SOPS, WIs, Safety Committee Charter, etc.
• Support US Safety Risk Management on Risk Evaluation and Mitigation Strategy (REMS) programs.
• Work with UBC vendor to assess REMS program effectiveness through patient and provider surveys (including KAB Protocol and Surveys).
• Ability to measure compliance with REMS (including enchanced pharmacovigilance procedures to collect events of special interest such as seizures).
• Manage and liaise with REMS Team Stakeholders (Medical Directors, Legal, Drug Safety, QA, Regulatory Affairs, and Commercial) for data mining and analysis.
• Represent Drug Safety/Narrative writing as the REMS project owner in order to ensure timelines are met.
• Author REMS assessment report template circulate to subject matter experts for comments, and address comments.
• Collaborate with affiliates to align REMS programs.
• Liaises with business partners/vendors to ensure compliance with SDEAs on REMS.
• Work with external vendors to facilitate REMS project execution.
• Support VP in developing REMS medical response letters.
• Support ongoing FDA inspection readiness activities including maintenance of department’s .
• Records, compliance with regulatory reporting timelines and SOPs, ensure quality of reports and participate in FDA inspections.
• Support UBC vendor in case processing resolutions as needed and form a strong alliance with UBC to ensure that all FDA requests are fulfilled in a timely manner and REMS commitments are executed.
• Clinical responsibilities include case review of clinical cases and ability to draft and/or review the safety sections of clinical documents in preparation for a clinical trial (including SAE forms and guidelines, study protocol, SMP, DMP, Coding Conventions, Reconciliation forms, etc).
• Responsible for the quality control of all risk management documents and FDA submissions on risk management.
• Point of contact for correspondence to FDA on risk management activities.
• Responsible for quality responses to audit reports of REMS documents, PADERs, FDA mock inspections, etc.
• Assist with FDA inspections pertaining to the project management and other activities on the REMS.
• Assist VP with Oracle Argus implementation project.

Senior Drug Safety Associate

Confidential

Responsibilities:

• Report to Senior Director/VP of DSRM and serve as Project Manager of case management.
• Authors material and conduct on case management and narrative writing, SharePoint portal, standard operating procedures (SOPs), work instructions (WIs), coding conventions, data entry conventions, licensing agreements (SDEAs), process improvement documents, etc.
• Responsible for creation and maintenance of role-specific matrix for the Drug Safety department containing all the documents each individual needs to train on based on their functional role.
• Maintain records updated and send out reminders as needed to complete s by due dates.
• Develop and deliver presentations on Pharmacoviligance, Risk Management and Safety Systems using MS PowerPoint, MS Project, webex and other web-based interactive tools.
• Conduct complete medical and quality review of all domestic and foreign reports for all company pharmaceutical products including clinical SAE reports of investigational products received from clinical trials and spontaneous AE/SAE reports of marketed products received via call center/literature searches/etc.
• Follow case processing management of Clinical Case Reports and Spontaneous Individual Case Safety Reports/Narrative writing (domestic and foreign reports) through case approval and closure.
• Review all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet.
• Produce Clinical Safety Queries and query trackers as needed for clarification and tracking of reports.
• Create and maintain workflow trackers, flow charts, Power Point slide presentations as needed.
• Serve as a Safety Liaison contact to other departments and Acorda licensing partners and affiliates (Medical Affairs/Regulatory Affairs/Biostatistics/Clinical Affairs/Quality/Project Management/Specialty Pharmacy Providers.
• Interact on a regular basis with Clinical Project Managers, Case Processing Managers, Medical Affairs, etc to identify process improvement strategies and communicate project status updates.
• Interact on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues.
• Active participation in the slide development for Advisory Committee and Confidential approval.
• Involved in safety submissions to FDA, SDEAs, Medication Guides, REMS, post-marketing commitments to FDA.
• Conduct QC review by verifying data against sources document including PADERs, responses toregulatory authorities, submission components (Summary of Clinical Safety and Summary of Clinical Efficacy, etc) to ensure accuracy and internal consistency.
• Serve as a contributor author of the SCS and SCE submission components.
• Generate reconciliation reports, address and investigate late case transfers to/from licensing partners.
• Request database output for data analysis and trending.
• Ensure quality control of clinical data by performing quality checks on clinical coding reviews for AEs and concomitant medications, conducting source verification for all clinical and spontaneous cases and working with QA on audit reports.
• Assist the Director with the creation of department SOPs, SWPs Guidance Documents, Forms.
• Assist VP with Risk Management projects, and Oracle Argus implementation project.

Confidential, Bridgewater, New Jersey

Affiliate Safety Specialist/Narrative Writing

Responsibilities:

• Facilitates safety data management and analysis by optimizing quality documentation, data management and assessment of individual case safety reports (ICSRs) from spontaneous adverse drug reactions and serious adverse events from certain Clinical Studies for all Confidential - Confidential pharmaceutical products and devices marketed in the United States.
• Collects and summarizes information on domestic adverse events via phone, e-mail, or fax for accurate data entry into Siebel Data Entry Database.
• Adheres to template for writing clinical narratives for ICSRs.
• Prepares a clear and concise narrative of the adverse event for company products including oncology clinical cases.
• Source data verification and overall quality review of vendor-prepared ICSRs including data entry, coding and narrative writing.
• Data enters domestic adverse event data (from spontaneous and clinical trial reports) into Clintrace Safety Database.
• Codes according to controlled vocabularies
• Searches database to prevent duplicate entries.

Confidential, Montvale, NJ

Drug Safety and Drug Information Associate

Responsibilities:

• Triage calls coming from consumers and healthcare professionals to the Drug Information Call Center.
• Provide up-to-date drug information according to monographs including drug-drug interactions, dosing, prescribing information, ingredient/package insert / MSDS sheet requests, AB drug ratings.
• Work closely with internal departments and business partners to obtain additional drug-related data.
• Collect appropriate data in adverse drug events for non-serious and serious reports, product complaints and data enter into Oracle Argus database.
• Write clear and concise narratives for ICSRs including oncology clinical cases.
• Draft responses for medical inquiries from internal and external sources.
• Working knowledge of department SOPs, FDA guidelines and regulations, ICH, Oracle Argus database, MEDDRA.
• Authored, managed and quality reviewed clinical documents across all therapeutic areas including the oncology pipeline.
• Responsible for reconciliation of drug safety databases and clinical study databases for adverse event reporting and follow-up.
• Train and mentor new hires on narrative writing processes.

Confidential, Bound Brook, New Jersey

Senior Certified Pharmacy Technician

Responsibilities:

• Train and supervise technicians in district pharmacies to prioritize workflow.
• Assist pharmacists with compounding prescription and OTC medications.
• Data enter prescription specifications into Intercom Plus database.
• Employ advance technological equipment to fill prescriptions.
• Effective communicator and team player overseeing all steps involved in the filling of a prescription.

Confidential, Dumont, New Jersey

Pharmaceutical Marketing Research Assistant

Responsibilities:

• Assist Project Manager in all stages of life cycle in data management of oncology clinical trials.
• Design Case Report Forms (CRFs) for oncology clinical trials and conduct analytical reports to ensure quality data.
• Examine clinical trial data format to create a data entry platform utilizing CSPro software.
• Applied advanced programming principles to navigate the CSPro data entry platform.
• Participate in creation of internal medical and drug name dictionary with emphasis on brand-generic relationships, therapeutic classes, dosage forms, labs, x-rays, etc.