Safety and Clinical data review, reconciliation, Adverse Event, SQL

DEBORAH INGRAM

**** ****** ** ***** *********, NJ 08902 732-***-**** ***********@***.***

SUMMARY Employed in a global pharmaceutical company (15+ years), functioning in the areas of Safety Data Management, Case processing and Operations & Logistics. Proven expertise and knowledge in the areas of reconciliation, document management (documentation, exchange, data retrieval and archiving) of Adverse Events from worldwide and local Partners, including Third Party Organizations -TPO’s, running periodic line listings and ad-hoc reports (from safety and quality database) as well as aggregate reports within the data lock point (DLP) timelines, regulatory submission of expedited cases to the Health Authorities, processing and coding adverse events using MedDra and Who dictionaries, created and authored relevant SOP (Standard Operating Procedure) and WI (Working Instruction) documents and providing compliance metrics for cases having medical and quality complaints. Running aggregate reports within the data lock point (DLP) and locking of the safety database. I am proficient knowledge of the clinical trial phases and processes. Hands- on training of the CRF paper design and EDC (electronic data capture) trials, writing edit checks and annotations, creating the data management plan, understanding the trial protocol, knowledge of the functionality of Metadata Rave and understanding GCP’s and ICH guidelines leading to the Clinical Data Management certification. I’m currently, taking courses to complete my degree in Public Health.

EDUCATION Rutgers University, New Brunswick, NJ

Bachelors of Science (expected date of graduation 2018 – Public Health)

` Mercer County College, West Windsor, NJ

Clinical Data Management (Certificate in Drug Development & Regulatory Affairs)

Global TechForce Inc, Edison, NJ

Base SAS - Programming

DeVry University, North Brunswick, NJ

Associate of Applied Science (A.A.S.) degree - Computer Information Systems

(Computer Programming)

SKILLS Languages Operating Systems Applications

Visual Basic Windows 98/NT Microsoft office (Excel, Access, Oracle/SQL Unix/Linux PowerPoint) C/C++ TCP/IP Argus (safety)/CRTS (quality)

JAVA /html Windows XP Register

SAS Citrix SharePoint

Open Clinica Toad

EXPERIENCE

Glaxo Smith Kline (a Novartis Healthcare Company) - Drug Safety, Pharmacovigilance Alliance Associate: (Jan 2016 – Sep 2016)

Supported the company with all processes, training and mentoring to ensure a smooth and cohesive transition of the joint venture objectives

Novartis Consumer Healthcare - Drug Safety

Pharmacovigilance Alliance Associate: Drug Safety/Operations (May 2002 – Jan 2016)

Liaise with global QA regarding the ICSR (individual Case Safety Report)data of quality complaints with medical AE’s

Run and reconcile weekly, monthly and quarterly reports for reconciliation of all quality complaints

Reconcile and ensure compliance of data within PVA’s and Medical Device agreements

Provide input for process changes and root cause analysis for reconciliation discrepancies

Group lead for document management processes

Modify queries as needed for data criteria (e.g. QA investigation site and/or TPO)

Create and/or author relevant SOP’s and WI’s documents

Liaise with and provide support to global affiliates and TPO’s (Third Party Organizations)

Liaise with the Novartis Knowledge Center (NKC) and global affiliates regarding NCH literature searches (using MedLine and Embase)

Novartis (hands-on) mentoring on the Clinical Data Management /Clinical trial Phases (I - IV)

Perform ad-hoc searches and run line listings in Argus and CRTS database

SME (Subject Matter Expert) during internal and external audits and inspections

Functionally responsible for all responsibilities of a assigned direct report

Currently responsible for the start-up of a PVA reconciliation group (PVA metrics and compliance) – for data compliance

Drug Safety Associate: Safety Data Management (SDM) (2004 – 2008)

Running PSUR (Periodic Safety Update report) and USPR reports and ensuring timely deliverable prior to data lock point (DLP)

Reconciliation of all TechMed (quality complaints/medical events) reports

Create data needed in APR (Annual Product Review) and Baseline reports

Maintenance of labeling for NDA, IND and Monograph products

Provide data for (15 day) expedited cases for KPI reporting

Create and modify queries (SQL) for data retrieval

Responsible for the submission of expedited cases to the health authority

Knowledge of FDA’s 21 CRF and ICH Guidelines

Data Reconciliation of AE’s/SAE’s (Argus and CRTS databases)

Responsible for ensuring timely case deactivation of NCH cases

Subject matter expert (SME) of quality and medical reports during audits

Process and code medical events in the Argus database – using MedDra

Assisted in writing Pharmacovigilance Agreements (PVA)

Drug Safety Associate (DSA): Case Processing (2002-2004)

Assisted in the data migration and system validation from CRS (Consumer response system) to

Argus Safety database

Database initial and follow-up adverse events (AEs) and/or serious adverse events (SAEs) from basic book-in thru full data entry (FDE) and narrative writing

Lock/close cases for expediting reporting (globally)

Responsible for submissions for regulatory reporting to the Health Authority (HA_ FDA) in timely manner

Tracking of submissions for use in KPI (Key performance index) summary

Coding of AE’s using MedDRA and Who dictionaries

Responsible for collecting and maintaining labeling information of NDA and monograph products

Knowledge of FDA, EU and ICH guidelines

Cardiology Partners of New Jersey, East Brunswick, NJ

Office assistant April 2002 – April 2002

Responsible for all office functions relating to patient care

University Orthopedics, New Brunswick, NJ

Medical billing Sept. 2000 – April 2002

Responsible for the submission of the HCFA 1500 medical claim forms

Medical billing (CPT and ICD-9 medical coding) and medical terminology

Cardio Medical Group, Edison, NJ

Office manager/ Medical Billing Dec. 1994 – Sept. 2000

Managed front desk operations for three (3) offices and twenty (20) employees

Solely responsible for staffing and training of personnel for all offices

Responsible for physicians credentialing to various hospitals

Liaison with physician and AMA representative during audit(s)

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