Management Safety

Vigneshwar Raju

E-Mail: *************@*****.*** Phone: 551

*** ****

Summary:

* Over 2+ years of experience as Drug Safety Specialist /Clinical Research

Archivist.

* In depth knowledge of coding principles, submission criteria, regulatory

time line requirements and technical requirements.

* SUSAR identification and reporting.

* Work remotely interfacing with ARGUS safety database, MedDRA and WHODrug

coding.

* Thorough understating of Clinical Research process, FDA regulations,

IND, NDA, ICH and 21 CFR Part 11 guidelines.

* Participated in the triage process of incoming adverse event cases to

ensure timely and effective assessment and evaluation of cases

* Responsible for Triage cases, Data entry and submission to internal

process flows and follow up until final submission to regulatory

authorities.

* Received and processed individual case safety reports (ICSRs) from

clinical trial, spontaneous and from published reports.

* Represented Drug Safety Quality on department teams.

* Tracked departmental regulatory reporting compliance metrics and audit

findings.

* Responsible for understanding the clinical development team on corporate

safety processes and provides comments consistent with department

guidelines and clinical safety issues.

* Good leadership, analytical, problem solving and time management skills.

* A team oriented professional who works well under pressure with

commitment to extracting research.

* Excellent communicational skills both in verbal and written.

Technical Skills:

. Hands of experience on Argus 4.0, MedDRA and Clinical Trial Management

Systems (CTMS)

. Sound knowledge on Adverse Event Reporting Systems (AERS) and Thesaurus

management system (TMS).

. Hands of experience in Microsoft Office and Adobe.

Education and Certification:

. Bachelor of Pharmacy from Dr.MGR Medical University, India.

. Master of Pharmacy from Dr.MGR Medical University, India.

. Certification in Java/J2EE from NIIT, India.

Project Dissertations:

. Evaluation of behavioral activity using monoamine depletor DSP4;

Effect of memantine.

. Synthesis of Anti oxidant and Anti microbial activity of 4-[2-(2-

Hydroxyphenyl)-4-oxo-1,3-Thiazolidin-3-yl] Benzohydrazide.

Trial Experience:

Title Sponsor Status

Prospective and historical, multi- centered phase Mylan Completed

IV study on Thermally injured patients.

Prospective, multi-centered phase III study on BMS Ongoing

Hepatocellular Carcinoma (HCC).

Prospective, multi-centered phase IV trial on Bayer Completed

Venous Thromboembolism.

Prospective, multi-centered trial on Phase II GSK Ongoing

asthma patients.

Professional Experience:

Sr.Drug Safety Specialist.

In Contract -(Aurolife Pharma USA Inc)

Mar 2013 to Present

. Ensure timely and accurate peer review of cases to meet client and

regulatory reporting requirements.

. Ensure regulatory compliance with timelines for individual expedited

case report submissions and timely delivery of information for

aggregate reports and other regulatory documents as requested.

. Peer review data entered cases to verify accuracy, consistency, and

compliance with process requirements, and review case data for special

scenarios.

. Determine if appropriate case follow-up has been considered. Conduct

follow-up activities when needed.

. Develop and maintain expertise of all assigned products, of

applicable corporate policies and local regulations, guidelines,

Standard Operating Procedures and writing practices, of data entry

conventions, and of search functions in the safety database.

Drug Safety Associate

Pfizer Inc. / Accenture. March 2012

to Feb 2013

. Registering the reports as cases in global database Argus 4.0 after

ensuring the validity of the reports with minimum set criteria,

searching the database for similar reports preventing duplicate

entries.

. Hands of experience as a SME working on various Pharmacological areas

with special reference to Cardiology, Oncology and CNS.

. Transcribe cases, write narratives and perform medical coding of the

data using CDD, WHODD and MedDRA.

. Assessing the seriousness of the cases dealing with various

therapeutic areas like Cardiology, Oncology, CNS and coding the events

with appropriate preferred terms, MedDRA and guidance documents.

. Performing daily responsibilities in compliance to all applicable

Standard Operating Procedures (SOPs), regulatory requirements,

conventions, and company policies.

. Create concise, accurate and well-written case narratives available

from relevant, related information from various source documents.

. Represented Drug Safety Quality on department teams.

. Ensured compliance with local expedited regulatory reporting

requirements for marketed and investigational products utilizing E2B.

. Provided support to ensure department audit preparedness.

. Tracked departmental regulatory reporting compliance metrics and audit

findings.

. Prepared and generated cover letter and ADE report in a MedWatch

format for submission to regulatory authorities.

. Followed-up safety reports until adverse event resolution or

stabilization.

. Assessed follow-up, lock, and distribute/archive non-serious cases.

. Communicated with medical directors to ensure accurate individual case

safety reports.

Clinical Data Coordinator

Bayer Inc / Apollo Groups, India. Feb 2011 to

Feb 2012

. Prepare key documents for Investigator Brochures ("IB"), regulatory

submission documents, internal/external presentations, and related

documents to support clinical research and drug development for

Inflammation & Immunology, Dermatology and Rheumatology.

. Prepare protocols and guidelines, including writing, reviewing,

amending and cross-functional facilitation as appropriate, and

collaborating with Key Opinion Leaders as required.

. Prepare and review clinical study reports in order to determine

potential drug indicators and clinical development plans.

. Prepare summary documents based on review of scientific literature for

inclusion in IB, protocols, and regulatory submission documents.

. Collaborate with the project physician to direct the planning and

implementation of clinical programs to meet corporate and clinical

research goals.

. Collaborate and support operational objectives as needed. Assist in

establishing project budgets and Standard Operating Procedures, and

reviewing ongoing study data including: safety, primary efficacy

variables, and laboratory data.

. Participate in and assist with advisory/scientific boards. Prepare and

present clinical data at external scientific/board meetings as needed.

. Provides Clinical Management with regular study updates/status reports

on study data.

. Assist with budget projections for clinical activities (such as

consultants, advisory board meetings, etc.) for assigned clinical

programs

Environment: Argus 4.0, MedDRA 15.0, Clinical Trial Management System,

Adverse Event Reporting Systems (AERS), Thesaurus management system (TMS),

Microsoft Office.

References available on Request.

Contact this candidate