Advanced Drug Safety Professional Resume NJ - Hire IT People

SUMMARY:

Experienced healthcare professional with extensive experience in patient care and clinical research focused on adverse event reporting of investigational and post - marketed drugs.
Trained in pharmacovigilance and working with global safety databases.
Highly organized with extreme attention to detail.
Works well in a challenging, fast-paced environment independently as well as part of a diverse team.
Over 5 years of experience working in Pharmacovigilance and Drug Safety
Systems/Computer Skills include: MS Office, Argus, SQL
Deep Understanding of Coding Dictionary such as MeDRA19.0
Languages: English, Hindi
Work Authorization: Green Card

SKILLS:

Experienced in Oracle Argus Drug Safety database (Version 8.0) and MedDRA (Version 19.0)
Understanding of ICH-GCP and HIPAA guidelines and GVP Guidelines
Experienced in Corrective and Preventive Action (CAPA) in analytical roles
Knowledge of 21 Code of Federal Regulation parts 11, 50, 54, 56, 312
Capable of Serious Adverse Event (SAE) reporting and Individual Case Safety Reporting (ICSR)

PROFESSIONAL EXPERIENCE:

Confidential, NJ

Advanced Drug Safety Professional

Responsibilities:

Focused on initial case assessment to determine validity and triaging cases to prioritize seriousness and expectedness/listedness
Conduct database searches to eliminate duplicate entries prior to case initiation/book-in
Using Oracle Argus Safety (version 8.0) Data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database and performing quality check of ICSRs
Write case summaries of gathered information into a concise clinical narrative, assessing causality, and writing CIOMS comments if required
Code adverse events and drugs using MedDRA and WHO Drug Dictionary
Generate queries to obtain missing case information and clarifications if required in Electronic Data Capture
Perform quality review for adverse events (AEs), serious adverse events (SAEs), and serious unexpected serious adverse reactions (SUSARs)
Assist with AE/SAE reconciliation prior to database closure

Confidential

Drug Safety Associate

Responsibilities:

Processed Confidential cases from various sources such as clinical trial, post-marketed, literature solicited non-serious and serious adverse event cases
Performed duplicate case search and accurately captured patient, product, and event data in Oracle Argus safety 8.0.
Triaged and coded medical history, laboratory and other investigational test results, adverse event terms using MedDRA 19.1 and WHO drug dictionary
Wrote accurate and detailed clinical case narratives ensuring that all the relevant information is presented in the chronological order of occurrence.
Perform Accurately captured listedness /expectedness of adverse events researching Confidential and company core data sheet.
Generated queries using ARGUS interface for clarification, resolving and forwarding to next work flow and communicated to out-side sources to retrieve the required information on the case report.
Consistently used ARGUS features such as action items, contact log and work list for communication and for the follow-up requests. led appropriate case follow-up, generating and requesting follow-up letters.

Confidential

Drug Safety Associate

Responsibilities:

Triage, Data entry, creating new cases, searching for duplicate cases and extract information from the data base.
Serious Adverse Event (SAE) Reports Processing using Oracle Argus (V 7.0).
Processing Suspected Unexpected Serious Adverse Reaction ( Confidential ) cases, strictly compliant to 7-Day and 15-Day timelines.
MedDRA coding, Narrative Writing and processing different cases.
Assuring medically cohesive narrative with completeness and accuracy.
Assessing causality and expectedness of adverse events as per documents .

Confidential

Executive Medical Administrator

Responsibilities:

Gathers patient information by collecting demographic information from a variety of sources; interacting with registration areas and physicians' offices; retrieving information from automated printer.
Maintains master patient index by completing assigned portion of daily audit trail; corrects and communicates problems according to established procedures.
Initiates the medical record by creating and processing the patient care record folder.
Maintains record availability by processing charts into the department; using chart mark-off procedures; facilitating chart location activities.
Retrieves medical records by following chart-out procedures; documenting reasons charts cannot be retrieved for statistical and follow-up purposes.
Delivers charts to assigned areas of the hospital by following established routing procedures.

Confidential

Gynecologist Assistant

Responsibilities:

Performed gynecological exams for patients.
Diagnosed common vaginal conditions such as yeast, bacterial or urinary tract infections