Pharmacovigilance, Project Manager Quality Control Clinical Research

SME Pharmacovigilance Analyst III Global Pharmacovigilance & Clinical Safety Operations

Alexion Pharmaceuticals

April 2011 – Present (2 years 9 months)USA

Vendor Management

Pharmacovigilance Analyst III SME PV

Alexion

April 2011 – Present (2 years 9 months)

•Assess reporting of Serious Adverse Events, triaging/reporting of cases based on seriousness and expectedness.

•Processes expedited reports in the safety database (Oracle-Argus) and submit to regulatory and health authorities per expedited reporting requirements (post-marketing, clinical trials, IIT, SUSAR’s, serious infections, death and life threatening adverse events, literature cases)

•Preform all processing according to current SOPs, WPDs and conventions

•Ensures compliance with health authority regulations in regards to drug safety data processing and reporting.

•Interacts daily with regulatory affairs on case submissions (US, Japan, Canada, Australia, South America..)

•Review and processing Serious Adverse Events for several ongoing Clinical Trial Protocols (US, EU sites)

•Cross functional communication with medical information, regulatory affairs, commercial, and data management in regards to Pharmacovigilance issues/activities

•Clinical Trial SAE case and narrative review, asses for submission to appropriate health authorities

•Assists in the oversight of electronic and hard copy document management, retrieval, and archiving of PV information including individual case summary reports to partners, CROs, and health authorities

•SAE reconciliation (post-marketing and clinical trials)

•Ensure processing of cases adheres to updated health authority regulations and guidance documents, including those from ICH related to PV

•Preform additional assigned tasks and projects such as QC of SOPs, WPDs, assist with updates Monthly/Yearly Metrics spreadsheets DSUR and PSUR’s

•Participate in training update activities, webinars, DIA presentations, Regulation updates

Regional' Clinical Research Monitor Oncology Studies

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April 2010 – April 2011 (1 year 1 month)

Liaising with investigators, medical staff, clinical research staff and lab staff during Site Initiation Visits and Monitoring Visits for oncology and hematologic malignancy clinical research trials

Setting up the study centers, ensuring each center has the trial materials necessary to conduct the trial along with training site staff to trial-specific and current industry standards

Training site staff to industry standards

Monitoring the trial throughout its duration, visiting the study centers on a regular basis (6+sites to be monitored each month, monitoring visits duration 2-4days)

Source data/document verification (SDV)

Collecting completed CRFs from hospitals and general practices

Composing Site Monitoring Visit Reports

Filing trial documentation and reports

Ensuring all trail supplies are accounted for, QC of pharmacy and documentation during site visits.

Archiving of study documentation and correspondence

Actively communicating with clinical team members, including participation in team meetings and updates.

Managing Institutional Review Board (IRB) and informed consent documentation

Participated in investigator recruitment and site selection visits.

Monitoring and reporting of adverse events adhering to FDA reporting regulations and GCP

Project Manager for External Biomarker Studies

Pfizer Clinical Research Unit

December 2008 – October 2009 (11 months)Pfizer CRU

Coordinated budgets and logistics for external biomarker protocols.

Served as contact point for external biomarker labs/sites.

Maintained internal database of study results including quality control (QC).

Assisted with regulatory submissions.

Oversaw creation of project timelines.

Scheduled conference calls

Documented and communicated gap analysis

Performed lab duties including phlebotomy, processing, assays, biomarkers, and PYY studies. (PIMS, LIMS)

Recruitment/Quality Control Compliance Auditor

Monitored and archived study specific documents for phase 1 clinical trials, in accordance with FDA ICH and GCP guidelines.

Review of volunteers/subjects files for accuracy and completeness

Responsible for maintenance and review of individual research subject records: medical records, lab reports, treatment schedules and other vital protocol-related information.

Clarified/discussed data deficiencies with research staff

Participated in the development and implementation of a corrective action plans as needed for deficiencies noted in audit reports.

Maintained security and confidentiality of patient/protocol information.

Confirmed study documentation (regulatory, IRB communications, patient and drug logs, etc.) had been appropriately filed.

Assisted in preparing all study-related files for storage in a permanent and secure location.

Assisted the research team in the maintenance of all required regulatory document files, including reports to sponsors (pharmaceutical companies), regulatory agencies (FDA) and the Human Investigation Committee (HIC).

Drug Safety Associate

Bayer Pharmaceuticals

February 2006 – September 2007 (1 year 8 months)

Promptly and accurately interpreted and documented U.S. non-serious and serious adverse events into the global database for distribution.

Created comprehensive narratives procured from relevant, related information from various source documents.

Performed the preliminary assessment of cases regarding the seriousness, determination of global listedness/labeledness, and causality of all incoming U.S. non-serious and serious adverse events. (AE/SAE).

Requested follow up information from the appropriate reporter for completion of case reports for submission within specific timelines, adhering to local and global regulatory guidelines.

Responsible for Coding of U.S. non-serious and serious adverse events using terminology set by global regulatory authorities (MedDRA, LLT, preferred term).

Generate necessary safety reports from global database with minimal supervision.

Experienced with CLINTRACE/ORACLE

Seinor Drug Safety Analyst 111

Purdue Pharmaceuticals

December 2006 – March 2007 (4 months)

Preformed review of cases, post initial data entry, Identify adverse events, seriousness and listed/ labeled for Identify potential product complaints

Reviewed follow up information, determine if follow up reporting was needed

Case assessment

Training and implementation of narrative writing.

Perform all appropriate coding (medical coding)

Compose initial and follow up narratives.

Prioritized/triage cases to be processed daily, according to reporting guidelines, 7day and 15 day reports.

Determine follow-up requirements and recommend follow-up type (phone call, letter, etcetera); formulate and generate queries

Perform own QC of reports, final review and submission of reports

Performed reconciliation of SAE’s

Contribute to production PSUR (DSUR, case and data clean-up reconciliation)

ARGUS : Clinical Data Management System

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