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Medical Data Entry

Location:
Washington, District of Columbia, United States
Posted:
April 20, 2017
Email:
aczwng@r.postjobfree.com

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AMIR M. SALAHMAND

**** ********* ***. **

Washington DC, 20007

(202) ***-****

aczwng@r.postjobfree.com

aczwng@r.postjobfree.com

Objective: Device/ Drug Safety/ Clinical Scientist

SUMMARY OF QUALIFICATIONS:

Causality Assessment according to source, seriousness, data entry priority, initial vs. follow-up report, relationship and Monitored clinical site by phone, email and e Fax; triage and assigned priority to incoming adverse event case evaluation for expectations according to the protocol, investigator brochure, package insert.

Processed Cases: identified and distributed case for processing, performed data entry and MedDRA/WHO coding of case (AE terms, drugs, medical history), wrote narratives, identified missing case elements (if any) and generated draft report and case assessment.

Performed Case Review; ensured that regulatory, scientific and medical standards.

Reviewed and screened regulatory documents and protocols; standard operating procedures (SOP), searched safety database and applied regulatory policies, procedures.

Liaised with Clinical Research Clinical trials, Drug Regulatory Affairs and Medical Information.

Attended departmental onsite project meetings and hosted internal and external partners and stakeholders for medical communications,

Tracked queries, corrected database and delivered to investigator; prepared and maintained adverse event (AE) reports, Case Report Forms, Med Watch Forms and edit checked for accuracy, review of adjudication to assure consistent

Knowledge of Clintace/Argus/MedDRA / Mediate Rave Databases (adverse events, validation medical and drug information electronic or manual, Clinical data management/Data Fax and electronic medical record systems for data capture, retrieval and analysis of safety reports.

Medical knowledge of individual medical case review that cases meet quality standards before approving for submission to regulatory

Medical knowledge and skills in clinical and therapeutic area in Oncology, Neuroscience and Infectious Disease.

Review of medical literature and medical publication for data extraction and data entry into database for Clinical Evaluation Reports and medical device safety surveillance.

Captured analyzed and interpreted clinical information, reviewed Clinical Study Reports from a scientific safety perspective.

Knowledge of relevant FDA, GCP/ ICH guidelines, initiatives and regulations governing both safety reporting and processing fand or Device Evidences Reports (DER) and evaluated product complaints.

Knowledge of drafting, present on scientific and clinical issues.

Knowledge of Medical information for intake, processing, and responding to external and internal Medical information.

Knowledge of Patient Safety (Pharmacovigilance) for reporting post-marketing adverse events.

Identify Case Report Forms, preparation of clinical evaluation reports, post-market surveillance activities, and literature review activities.

Provided assistance in submission for IND Annual Reports and aggregate reports. Communicate

Pharmacovigilance documents, adverse event reporting forms, and standard operating procedure manuals for treatment efficacy studies,

Assessments on pharmacovigilance and regulatory agency activities.

Tracked and monitored project issues, escalated to the appropriate management level as needed

Maintained overall project schedule and the execution & delivery of expected project milestones

Managed project budget by monitoring, forecasting and making adjustments.

Reported weekly on project progress, budget, schedule and milestones, issues and risks

Actively led, motivated, and challenged cross-functional teams

Facilitated project meetings with a published agenda and followed-up.

Developed relationships with key project stakeholders and fostered a positive, collaborative working environment

Anticipated and adjusted for problems and roadblocks.

Assists and/or participates in planning and conduct of investigator’s meetings.

Collaborates with the cross functional team on selection and potentially management of clinical.

Monitors the status of clinical data collection of assigned clinical studies.

Reviews clinical monitoring reports and correspondence related to monitoring visits.

Responsible for maintaining tracking information in the clinical trial management system

Monitors of the clinical study, ensuring it is conducted in accordance with the approved study plans.

PROFESSIONAL EXPERIENCE:

Siemens Healthcare, Mountain View, CA. 2016- 2017

Medical Device Reporting/ Clinical Scientist (Contactor)

Receive and assess product comments to determine need for complaint handling record.

Document required information in Global Complaint Handling (GCH).

Assisted/ Coordinated Performs literature searches and drafting document content. Interprets literature information for Clinical Evolution Report

Assess complaint file for missing required information.

Reporting/submission of safety information (including expedited and aggregate reports) related to Device products from a variety of sources (clinical trial, spontaneous, literature), both U.S. and foreign, in compliance with SOPs, US regulations, and international regulations.

Communicate with outside parties in a professional and

Provide safety content review of clinical protocols, study reports, Investigators Brochure

Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.

Initiate complete regulatory reports for timely submission to FDA and other regulatory bodies.

Determine if investigation is necessary.

Summarize the results of any investigation.

Complete electronic submission of MDRs to the FDA (Initial, Supplemental and MedWatch Form)

Johnson & Johnson, Warsaw IN. 2014- 2016

Center for Health Care Resources

Device Safety/ Clinical information Specialist (Contactor)

Follow up with reporters for missing information or event details on Device Evidence Report Form

Processed adverse event for devices concerning marketed products.

Performs signal detection monitoring and evaluation based on single cases.

Reviewed serious adverse event reports to identify missing, inconsistent or erroneous data and check for duplicate cases.

Performing safety surveillance on investigational product

Enter safety data into the safety database and interpret the received report

Utilize MedDRA dictionary for coding clinical events.

Adverse safety event review process within Depuy Synthes Orthopedics,

Processing, review, manual medical coding, follow-up and reporting of safety events as part of the safety management within Clinical Projects and Registries.

Assisted with Submission of Periodic Safety Updates (US Annual Reports, DSURs)

Literature review process, the extraction of literature data and production of final Clinical Evaluation Reports for medical device safety surveillance.

Clinical Data management, Monitor/ Safety Officers and Complaint Handling Unit/ Vigilance with management of adverse events.

Tracking and complete safety reporting for assigned clinical studies and registries according to appropriate regulations.

updating safety SOPs, and ensuring compliance with internal standards

Coordinated with internal Operating Company Quality and Medical Affairs Leads/Medical Monitors

Track and ensured complete adverse event reporting for all assigned clinical studies and registries.

Reported/ tracked the final disposition of all applicable adverse events to appropriate departments within the company, within the required periods.

Track/ safety reporting, including any serious or unanticipated adverse event.

Complaint Handling Unit on potential reportable events and event investigations.

Tracks and reconciliation of reportable events between Regulatory and Complaint Handling Unit.

Site monitors for concerns/issues raised from adverse event reporting.

Manually code medical terminology, as required, for assigned clinical studies.

planning, organization and follow up of safety review committee

Review and tracking of adverse/safety events and compliant with appropriate regulations and procedures.

Drafting, formatting research articles and maintain article in database.

Review of medical literature and medical publication for data extraction and data entry into database

support Strategic Medical Affairs and Clinical Affairs and participate at Investigator meetings

Harris Orkand/National Institutes of Health (Contractor), Bethesda, MD, 2012 – 2014

Sr. Drug Safety / Clinical Scientist

Processes and maintained data integrity

Reviewed data tracking; triaged and assigned the incoming reports

Prepares responses to regulatory agencies' questions and other correspondence.

Completed and quality controlled data entry of incoming report

Review of medical literature and medical publication.

Tracked and monitored project issues; escalated to the appropriate management level as needed

Maintained overall project schedule and the execution & delivery of expected project milestones

Managed project budget by monitoring, forecasting and making adjustments

Actively led, motivated, and challenged cross-functional teams

Facilitated project meetings with a published agenda and followed-up.

Developed relationships with key project stakeholders and fostered a positive, collaborative working environment

•Anticipated and adjusted for problems and roadblocks.

PSI International, Rockville, MD 2009– 2012

Drug Safety Specialist/ Medical Review

• Reviewed/ updated safety data reports.

Processed cases for Oncology therapeutics.

Presented product safety findings at internal meetings, documented information on adverse events.

Contacted research organizations as needed for clarification or follow-up regarding safety data issues and data management

• Reviewed, extracted and accurately entered AE data.

• Review of medical literature and medical publication for data extraction and data entry into database

Clinical Research in University Hospitals, 2000 - 2009

EDUCATION:

State University of New York, School of Medicine Health Science Center, Brooklyn, New York.

Fifth Pathway Program (Doctor in Medicine). 1990

Universidad Autonoma de Tamaulipas School of Medicine, H. Matamoras, Mexico. Physician Doctor. 1991

POST-GRADUATE EXPERIENCE:

University of Oklahoma, Health Science Center, Oklahoma City, Okla., Department of Neurology. 1994

DC General Hospital, Georgetown University Hospital, Washington DC, Department of Medicine. 1993



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