Customer Service Sales Representative

PROFILE

• Postgraduate diplomas in Regulatory Affairs and Clinical Research Monitoring with Bachelor of Science

• Over 10 years experience in the pharmaceutical industry complemented with Clinical Trial experience (Phase I, II & IV)

Pharmaceutical skills CRA

• Trained in GLP, GCP, ICH guidelines and FDA regulations and knowledgeable about the application process for Product, Establishment, Site and Medical Device Licenses

• Motivated team player, detail oriented, result focused with excellent time management and interpersonal skills

• Versatile, flexible and adaptable ; thrives on the challenges of learning and implementing new concepts/technologies and responsibilities; excellent verbal and written communication skills

• Outstanding presentation skills: can present materials effectively to large audiences

• Audited Investigator sites for compliance with clinical research protocol. Performed site visits and site close outs.

• Proficient in MS-Office (Word, Excel, Power Point)

Regulatory Affairs

• Researched Health Canada guidelines and requirements for preparation of CTA application

• Prepared clinical trial protocol, pre CTA package, IND, NDS applications submissions. Prepared cover letter for pre CTA application

• Performed site audits for GMP and GCP compliance

• Prepared SOP for clinical trial application form

• Maintained and classified the guidance’s and guidelines issued by Health Canada

• Reviewed statistical data for compliance for stability studies using P value

PROFESSIONAL EXPERIENCE*

CLINICAL RESEARCH ASSOCIATE SEP 2007 – JUNE 2008

Kriger Research Center Inc. (CRO)

• Member of the clinical development team for four projects Phase I Oncology (Bladder, Melanoma, Colon) clinical trial, Phase II Cardiovascular and Dermatology clinical trial, Phase IV study (Survey: Proper Use and Cost Reduction Strategies for Prescription and Non-Prescription Drugs), Reviewed protocol requirements, Drafted appropriate CRFs

• Meticulously researched and selected potential investigative sites

• Developed study timelines and detailed plan of study

• Developed templates for study initiation deliverables (checklists for site evaluation, initiation, monitoring, close-out; subject screening & recruitment, visit logs and drug accountability logs).

• Checked and corrected clinical trials SOPs and forms

• Trained to perform Pre-Study, Initiation, Interim Monitoring and Close-Out visits according to applicable SOPs, FDA regulations and ICH GCP guidelines.

• Issued letters of agreement/contracts

• Performed inclusion/exclusion criteria and evaluation of patient enrollment

• Reporting of adverse events in compliance with IRB stipulations and in accordance with FDA regulations and ICH guidelines

Marketing Assistant May 2007 – July 2007

Simfit, A Division of Job Skills, Mississauga, ON

Designed, documented and administered campaigns that will motivate purchases by internal as well as external clients

• Developed sales policies and procedures (pricing, credit, reimbursements)

• Conducted research on target markets; analyzed the findings and presented to management

Customer Service Representative July 2005 – May 2007

Teleperformance Canada (Bell Canada)

• Attended inbound calls and resolved billing issues

• Processed orders and provided product information

Sales Representative Jan 2005– April 2005

Dr. Green Lawn Care, Mississauga, ON

• Made outbound calls and generated sales leads for lawn care services

Manager

Health India Laboratories

• Phase IV study (Efficacy of Xeronine in diabetic patients)

• Reviewed protocol requirements

• Validation of inclusion/exclusion criteria and evaluation of patient enrollment

• Drafted clinical trial forms

EDUCATION & PROFESSIONAL DEVELOPMENT

Post-Graduate Diploma – Pharmaceutical Regulatory Affairs Jan 2009 – Present

Toronto Institute of Pharmaceutical Technology

Post-Graduate Diploma - Clinical Research Associate 2007 – 2008

Kriger Research Centre Toronto

Post-Graduate Diploma – Marketing Management 1996 - 1998

Indira Gandhi National Open University New Delhi

Bachelor of Science in Zoology with Chemistry and Geology as ancillary subjects

Madras University, Chennai (Evaluated as equivalent to a Canadian bachelor’s degree by the University of Toronto on June 3, 2005)

* References available upon request

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