AISHWARYA VENKATESWARAN

Email : adgoqu@r.postjobfree.com Mobile : 914-***-****

PROFESSIONAL SYNOPSIS

Close to 2 years of industry experience in the field of Biomedical and Clinical Research with focus on Quality Assurance

Certified GCP Analyst in Clinical Research, with experience in handling multi-national clients including but not limited to: 3M Pharmaceuticals, Lupin Limited, Mylan, Pfizer, Ranbaxy Laboratories, Ipca Laboratories, Cadila Healthcare, Aurobindo Pharma, Dr. Reddy’s Laboratories, Novartis, Sigma Pharmaceuticals, Sinopharm Group, Concordia Healthcare Group

Extensive work experience with QA-Auditing related activities including: Clinical Research, Documentation Review and Issuance of SOPs, Review of Case Report Forms, VRFs and Study Files, Conducting Facility Audit, Process Audit, Data Audit and Bio Study Audit for the Clinical Research activities, ensuring the close out of CAPA issued after audit, ensuring the close out Regulatory queries related to the studies conducted in the facility

Research experience in various projects that comprises of:

Transport Properties of Nano Manganese ferrite -Propylene glycol dispersion (Nano fluids)

Dispersion of Iron Oxide in Ethylene Glycol and Propylene Glycol

Application of Nano fluids in Automobile Industry

Drug Delivery applications of Nano fluids

Ability to initiate and drive improvements & articulate analytical information clearly and succinctly

An effective communicator with excellent relationship building & interpersonal skills. Strong analytical, problem solving & organizational abilities

Exceptional leadership, organizational, oral, written communication, interpersonal, analytical, and problem resolution skills. Thrive in both independent and collaborative work environments.

Skilled in building long-term relationships with all levels of hospital staff and pharmaceutical and medical equipment representatives. Achieved significant results related to promoting organizational growth and staff development, securing necessary industry-related designations, and increasing overall patient volume. EDUCATIONAL QUALIFICATIONS

2013 Master of Technology (in Medical Nanotechnology; 76.00%)

(from SASTRA University, Tanjore, India)

2012 Bachelor of Technology (in Medical Nanotechnology; 77.00%)

(from SASTRA University, Tanjore, India)

2008 Senior Secondary, with Distinction (88.83%)

(from Prince Matriculation Higher Secondary School, Chennai, India)

2006 Higher Secondary, with Distinction (89.27%)

(from Prince Matriculation Higher Secondary School, Chennai, India) CERTIFICATIONS & RECOGNITIONS

PROFESSIONAL CERTIFICATIONS

Certified in ‘GCP for Clinical Trials with Investigational Drugs and Biologics’, by CITI

Certified in ‘Functional Nanomaterials Research’, by Centre for Nanotechnology & Advanced Biotechnology (CenTAB), India

Certified ‘Biomedical Instrumentation Analyst’ from Apollo Hospital, India

Certified in ‘Basic Life Support’ from Indian Medical Association and Amenity Lifeline Emergency Response Team

Certified in Cancer Biology: ‘Molecular Mechanisms and Novel Therapeutics’ from IIT Madras, India

Certified in ‘Molecular Modeling’ from Sai Biosciences, India

Certified Trainer in GCP by Micro Therapeutic Research Labs, India RECOGNITIONS

Research Paper Publication:

Author(s): Aishwarya V (and K.S. Suganthi, K.S. Rajan)

Title: Transport Properties of Nano Manganese Ferrite-Propylene glycol dispersion (Nano fluids): new observations and discussion

Published By: Journal of nanoparticle research

Status: Accepted

IF: 3.28

Link: https://link.springer.com/article/10.1007/s11051-013-1774-3 RESEARCH STUDIES

Transport Properties of Nano Manganese ferrite -Propylene glycol dispersion (Nano fluids)

Dispersion of Iron Oxide in Ethylene Glycol and Propylene Glycol

Application of Nano fluids in Automobile Industry

Drug Delivery applications of Nano fluids

Clinical Trials on Human Subjects for studying BA/BE for molecules like Olanzapine, Budesonide, Mesalamine, Omeprazole, Esomeprazole, Atorvastatin, Clindamycin and Azithromycin OCCUPATIONAL CONTOUR

Since May’14 to April’15 Micro Therapeutic Research Labs Clinical Research Analyst

(Quality Assurance)

Client(s) : Aurobindo Pharma, Dr. Reddy’s Laboratories, Ipca Laboratories, Cadila Healthcare, Lupin Limited, 3M Pharmaceuticals, Mylan, Novartis, Pfizer, Ranbaxy Laboratories, Sigma Pharmaceuticals, Sinopharm Group, Concordia Healthcare Group

Drugs Administered : Olanzapine, Budesonide, Mesalamine, Omeprazole, Esomeprazole, Atorvastatin, Clindamycin, Azithromycin

Drugs used for Trials : Antibiotics, Antipyretics, Analgesics, Antimalarial Drugs, Disinfectants, Antivirals, Anti-allergics, Anaesthetics, Anti-inflammatory, Antiperspirants, Anti-tuberculous drugs

Type of Studies : Pilot, Pivotal, Clinical Phase, Bioanalytical Studies, Pharmacokinetic, Pharmacodynamics, BA/BE Studies

Types of Drug Administration : OROS, ODT, Syrup, Capsule, Tablet, Oral Spray, Suspension Responsibilities:

Responsible in assembling and coordinating the activities of the audit team

Conduct audits in accordance with Regeneron standard operating procedures and quality policies

Provide Quality Assurance support and guidance to clinical operations

Responsible for Quality Assurance Audit (QAA) projects associated with developing and managing risk assessments, CAPA, metrics, etc.

Responsible for gathering and interpreting regulatory intelligence, as well as evaluating internal practices, making recommendations for improvement, and executing against action plans

Interpret policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations

Exercise judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance

Appropriately escalate any compliance issues

Be involved in the investigations of suspected serious noncompliance

Communicate audit results to management and auditees through written audit reports

Manage post-audit activities and follows-up on any necessary corrective and preventive actions; resolves any conflicts

Assist with supporting regulatory facility inspections

Draft and issue periodic reports to site management as requested

Be involved in identifying and developing continuous improvement efforts

Assist with training/orientation of new QAA staff

Acquiring working knowledge of the technical concepts required for PV Auditing

Acquiring knowledge of FDA, EMeA and other international Quality System rules and regulations

Acquiring knowledge of pharmaceutical/biotechnology process and auditing standards

Communicate effectively and successfully manage conflict

Interpret applicable standards and objectively make decisions

QA Auditing of all the activities related to clinical research

Documentation, review and Issuance of SOPs

Review of Case Report Forms, VRFs and Study Files

Conducting Facility Audit, Process Audit, Data Audit and Bio Study Audit for the clinical research activities

Ensuring the close out of CAPA issued after Audit

Ensuring the close out Regulatory Queries related to the studies conducted in the facility

Facing the internal cross process audit and external audit from Sponsor, DCGI, IEC and close out of Audit observations

People Responsibilities:

Help my team and the trainees to come up to speed with business and technical knowledge

Proactively seek opportunities to broaden and deepen knowledge base and proficiencies among my team and myself

Conduct training for the analyst trainees

Since Jun’13 until May’14 Mrudaan Medical Technologies, India Clinical Data Analyst Client(s) : Apollo Hospitals, Santosh Hospital, MIOT Hospital, Sri Ramachandra Hospital & Medical College, PVS Memorial Hospital, Kovai Medical Hospital & Research Centre Responsibilities:

Complete clinical data investigations and present findings and feedback in an understandable and constructive manner to all levels of client project teams.

Develop reporting mechanisms for new go-to-market products.

Validating results and conclusions from experiments and data from research for use in clinical business intelligence systems.

Evaluate the safety, efficiency, and effectiveness of biomedical equipment’s.

Design systems and products, such as artificial organs, artificial devices that replace body parts, and machines for diagnosing medical problems.

Perform cross-customer analysis of alert outcomes and identify specific recommendations for customers to surface up to Implementation team.

Resolve errors, omissions or discrepancies in data.

Install, adjust, maintain, and/or repair biomedical equipment’s.

Overseeing data management activities, both external and internal.

Implementing study-specific procedures to ensure compliance with existing regulations and procedures.

Designing, deploying and testing data collection systems.

Develop internal monthly reports to support various business tasks such as Salesforce renewal or opportunity reports.

Provide weekly status reports on the status of open projects.

Assist with monthly, quarterly, annual support uptime and responsiveness reporting needs.

Summarize data findings for use in high level marketing materials or internal presentations.

Develop optimization recommendations based on data or report shortcomings.

Working with a wide range of medical, technical and administrative staff and, at times, patients and undertaking responsibilities like:

Writing reports and documentation

Liaising with medical, engineering and scientific staff

Maintaining equipment(s)

Teaching

Install, adjust, maintain, repair, or provide technical support for biomedical equipment

Evaluate the safety, efficiency, and effectiveness of biomedical equipment PERSONAL DETAILS

Name : Aishwarya Venkateswaran

Date of Birth : 27th January 1991

Passport No : M8321139

Residential Address : 2428 Little Current Dr, Apt 2824, Herndon, Virginia 20171, USA

Contact this candidate