SUMMARY:

Dedicated, high - energy professional with a diverse background advancing medical, clinical, and pharmaceutical initiatives. Focused achiever with experience participating in clinical trials, perform­ing mental health summaries and coordinating delivery of social services. Excellent experience serving on cross-functional medical/clinical teams related to regulatory processes, drug information, patho­physiology, pharmacology and pharmacotherapeutics. Strong interpersonal, communication, and rela­tionship building skills. Experience training physicians and clinical professionals on drug interaction and adverse effects.

PROFESSIONAL EXPERIENCE:

Confidential, Princeton, NJ

Clinical Safety Associate (CSA)

Responsibilities:

• Demonstrated ability to work within defined departmental standards and organized information from rough reports into a standard format .
• Completed the task by understanding the conventions and singularities of specific therapeutic areas.
• I have also achieved the reporting criteria by utilizing proper international and US regulations surrounding the processing and reporting of adverse events.
• Completed variety of re­ports by using specific and designed software and through my computer literacy and I have was also demonstrated my ability to learn new software applications to in corporate the international requirements.
• Completed AE processing functions using detailed knowledge of relevant GPL standards.

Confidential, New York, New York

Clinical Safety Associate

Responsibilities:

• Processed serious adverse event (SAE) reports per sponsor (Pfizer Pharmaceuticals) and Clinical Research Organization (CRO) Standard Operating Procedures (SOPs)
• Obtained follow-up SAE information from clinical sites and CROs including responding to outstanding queries for clin­ical trial reports
• Administration of SAE reporting of all medical safety data utilizing ARISg, MedDRA, and WHO-Drug databases along with MRA internal tracking system, Inquery, Investigo, Supertrack, and DSS Tracking databases
• Completed all work within acceptable quality standards and determined timelines
• Attended weekly staff meetings
• Participated in appropriate training pertinent to job performance

Confidential, Summit, NJ

Drug Safety Specialist

Responsibilities:

• Provide adverse event (AE) and Serious adverse event data collection, analysis, coding, and reporting of SAEs from all sources in compliance.
• Receive and process adverse event cases from all investigational products including assessment, coding, re­view and follow-up of adverse events in compliance with Domestic/ International Federal/ ICH Regulations and Celgene WWDSS SOPs.
• Ensure and maintain accurate and complete entry of adverse event data into the Drug Safety database with appropriate case follow-up, inquiries, and quality assurance till case resolution. Collaborate with site monitors or CRO PV team on an ongoing basis.
• Assist in compiling WWDSS written reports including the annual report and the Periodic Safety Update, when applicable
• Perform data reconciliation of AE and SAE line listing on a regular basis communicating effectively with the Celgene Clinical Research team.
• Prepare written narratives of AE Reports, and provide accurate and complete entry of adverse event data into the WWDSS Database with appropriate case follow-up, completion, and quality assurance. Provide departmental phone coverage support for the Confidential .

Confidential, Lawrenceville, NJ

Medical Clinical Liaison

Responsibilities:

• Leading global manufacturer with operations in 60 countries and distribution of leading product brands in 180 countries.
• Provided medical and technical expertise and project leadership to ensure awareness and appropriate use of Reckitt Benckiser products to physicians and ancillary medical professionals.
• Established and cultivated rela­tionships with current and future innovators and opinion leaders in the addiction therapeutic area.
• Reviewed investigator-initiated clinical research proposals exploring further on-label use of approved products and new potential clinical applications.
• Performed site screening and evaluation of potential products.
• Provided feed­back to Clinical Development and supported business management and product issues of clinical signifi­cance.
• Identified, secured, and developed advocates for speaker programs and formulary decisions.
• Provided advocates with literature searches, slides, and related clinical data.
• Championed awareness and appropriate use via medical education initiatives, advisory board mod­eration, data presentation to key decision makers, speaker training, and research initiatives.
• Collaborated with key internal customers to assist in development of product-specific medical pro­grams.
• Provided leadership for both internal and external projects as well as sales specialist training initia­tives.
• Acted as a medical liaison between the customer and Reckitt Benckiser organization.

Confidential, Cleveland, OH

Clinical Research Coordinator / Clinical Coordinator

Responsibilities:

• Coordinated progress and conduct of clinical trials. Facilitated clinical and administrative functions.
• Main­tained regulatory documents and completed source of documents, Case Report Forms, and study-related pro­ducers aligned with protocol.
• Cross-functionally interacted with pharmaceutical and clinical professionals related to regulatory processes and drug information.
• Delivered training for clinics and physicians on serious/non - serious adverse events.
• Facilitated oversight of regulatory processes and drug data relating to medical terminologies, patho­physiology, pharmacology and pharmacotherapeutics.

Confidential, El Paso, TX

Clinical Coordinator

Responsibilities:

• Coordinated clinical functions to source and deliver medical, social educational, and vocational services to enhance quality of life and community participation.
• Performed clinical casework, follow-ups, assessments, timely documentation and submission of information.
• Managed development of treatment plans in coordina­tion with patients and service providers.
• Extensively interacted with patients, families, and service providers to ensure timely intervention and service delivery.
• Orchestrated community resources and services to consumers to enable optimal functioning.