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Click here or scroll down to respond to this candidateCandidate's Name
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.
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Phone: PHONE NUMBER AVAILABLE
Email: EMAIL AVAILABLE
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