AARTHY CHANDRU

COMPETENCIES - JOB RELATED

. Understanding of Pharmacovigilance triaging of incoming reports

according to the seriousness criteria.

. Expertise in adverse event reporting and handling

Pharmacovigilance Safety Database, ARIGg.

. Understanding and working knowledge of Quality System Management,

Change Control and CAPAs.

. Proficient with all citations styles, Microsoft operating systems, MS

office, MS database and Adobe tools. Review and make recommendations

to customer personnel on applying regulations and policies to their

programs.

. Responsibilities also include the handling, scanning, copying,

indexing, data entry, reporting, and filing also archiving of official

records.

. Batch record archiving and issuance;

. DRA and WHO Drug Dictionary coding of all cases.

. Knowledgeable of hard copy and electronic records management processes

involved in the life cycle of record.

. Assist with training of departmental policies and procedures regarding

record retention.

. Assist with writing SOP's, Work Instructions and other departmental

processes.

. Collecting data; assisting with the clearance and dissemination of

written material; and managing paper and electronic record systems.

. Creating and updating existing binders, indexes, and files.

. Technical editing of product build specifications under direct

engineering supervision to include, SOP's, Work Instructions, Manuals,

labeling, and all other Process-Quality-Customer Service documents.

. Satisfy Current Good Manufacturing Practices and Good Laboratory

Practice regulations.

. Review process orders and use information provided to issue batch

records in a timely manner.

. Excellent organization, planning and problem solving abilities.

. Excellent negotiation and analytical skills.

. Established interpersonal and communication skills.

. Fluent in English.

. Able to work effectively and efficiently in a matrix environment.

WORK EXPERIENCE

Nov 2013 to Present

Clinical Research Assistant

Lang Research Center, New York Hospital Queens, NY.

My main responsibility is to provide support Study Manager

. To create agendas and meeting minutes

. Electronic study tracking and maintaining a shared electronic study

database.

. Responsible requesting information or to follow-up on action items.

. Responsible for responding to routine inquiries from internal and

external customers to ensure that critical issues are handled

appropriately.

. Act as a liaison for vendors.

My other responsibilities as a volunteer are to set up and maintain

tracking system for patient visits, contracts, budgets, invoices, vendor

and site payments, regulatory documents, IRB approvals, etc.

Aug 2009 to Apr 2011

Drug Safety Assistant/Associate

Employer: Orchid Chemicals & Pharmaceuticals

. Receive, process and distribute safety reports received from any

source or assigned

products and/or studies, according to ICH-GCP guidelines, regulatory

requirements and company SOPs, policies and procedures.

. Responsible for initial evaluation and assessment of incoming case

reports and source documentation for completeness, accuracy,

legibility, and consistency of information, and perform necessary

checks for duplicate cases.

. Generate concise, accurate and well-written case narratives and

reconcile SAEs in accordance with project specific guidelines.

. Communicate with partner companies, collaborative sponsors and their

respective clinical research organizations regarding the evaluation

and processing of case reports.

. Produce and distribute expedited and non-expedited individual

case safety reports to regulatory authorities, partner companies, and

other trading partners, as needed, to ensure compliance with

regulatory and company timelines.

. Communicate with partner companies, collaborative sponsors and their

respective clinical research organizations regarding the evaluation

and processing of case reports.

. DRA and WHO Drug Dictionary coding of all cases.

Nov 2008 to Jul 2009

Drug Safety Trainee Associate

Adverse Event Management Group

Dept of Biotechnology

Central Leather Research Institute.

. Triaging incoming reports for completeness, legibility and validity

and performed the primary evaluation of seriousness and causality of

the reports received directly from the consumers, Healthcare

professionals and post marketing sources by following local work

instructions and US FDA regulations and guidelines.

. Prepared and entered case reports data via

Pharmacovigilance Safety Database, ARISg.

. Review, rank, verify, process and document: event terms; case

classifications (validity, seriousness, and expectedness/listedness);

special scenarios; product complaint information; reportability with

due date; and accuracy and consistency. Based on assessment of cases,

process accordingly.

. Review case criteria to determine the appropriate workflow for case

processing.

. Write and edit the case narrative.

. Generate reports, ensuring adherence to regulatory compliance

timelines.

. Determine and perform appropriate case follow-up, generating and

requesting follow-up letters.

. Trained in DRA Coding and to assist in coding accuracy of cases. DRA

and WHO Drug Dictionary coding of all cases.

ACADAMIC PROFILE

M.S. Clinical Trials Sciences specialized in patient recruitment &

management. Rutgers - School of Health Related Professions, Newark, NJ.

3.65 GPA.

Bachelor of Technology (Pharmaceutical Technology)

Alagappa College of Technology campus, Anna University, India

7.35 CGPA. (Equivalent to 3.7 GPA as per WES evaluation)

IMPORTANT SUBJECTS STUDIED

. Drug Bio Evaluation

. Medicinal Chemistry and Industrial safety

. Pharmacology and Chemotherapy

. Clinical Research

. Neurobiology

. Pharmacokinetics

. Pharmacognosy

. Project economics

SOFTWARE SKILLS

Argus Lab Software, Microsoft Office applications (Word, Excel, PowerPoint)

with Basic computer and Internet knowledge.

INTERNSHIP, PROJECT AND TRANING DETAILS

June 2014 - Till now.

Training Program for Argus Drug Safety Management & Pharmacovigilance.

The Veritas HealthCare Solutions,

New York.

May 2009 to Aug 2010.

Lang Research Center. NYHQ

Clinical Research Assistant.

Final Year Project, MS Clinical Trials Science. (Management & Patient

Recruitment Track).

Design, develop and implement a multimedia based training and user guide on

topic of "Clinical Research Compliance, Regulations and Guidelines".

November 2008 to April 2009

Bio-Organic Department,

Central Leather Research Institute (CLRI)

Government of India enterprise for Scientific and Industrial Research.

Project - "Effects of natural products - Punica granatum L and Trigonella

foenum- graecum on wound healing in albino rats",

AREAS OF INTEREST

. Drug design and development

. Nutrition and Pharmacology

. Pathology

. Human Physiology

CO-CURRICULAR AND EXTRA CURRICULAR ACHIEVEMENTS

. Organized Industrial visit and field study at "Orchid Chemicals &

Pharmaceuticals Ltd".

. Attended plant and field visit in "Futura polyesters" Chennai, India.

. Active participant in nationwide technical symposium "Biotechellence".

. Active participant in AIDS awareness campaign organized by Youth Red

Cross.

Phone: +1-201-***-****

Email: acgjx0@r.postjobfree.com

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