Brinda Idnani

*** ********* ****, **********, ** 07054

732-***-**** / acdnbo@r.postjobfree.com

Twenty years experience in Pharmaceutical data administration and

analysis across multiple platforms (Global Pharmacovigilance, Sales &

Marketing, and Computer Operations). Multi-faceted, efficient and detail

oriented professional offers superb decision making skills, judgment and

outstanding initiative. Liaison with strong analytic, cost conscious and

customer focused strengths, utilizes innovative techniques and solid

management acumen. Extremely focused and motivated to achieve in a fast-

paced professional setting. Works hard and smart.

Novartis Pharmaceuticals Corp, East Hanover, NJ 2013 to now

Assistant Safety Data Manager Oct 2013 to now

- Responsible for archiving FDA receipts into OpsRadar Archiving System.

Attention to detail extremely important, so as to assure the receipts are

archived in the correct location for proof of submission of alert reports

to the FDA.

- Publish text format FDA receipts into PDF for electronic filing.

- Responsible for distribution of U.S. SAE generated queries to U.S.

investigator sites.

Bayer Healthcare Pharmaceuticals, Montville, NJ 2008 to

2013

Submissions Coordinator Sept 2011 to Oct

2013

- Accountable for submitting identified Serious Unexpected Suspected

Adverse Reactions (SUSAR) to Regulatory Affairs for submission to the FDA

for Bayer Healthcare Pharmaceuticals investigational products

- Compile and submit SUSAR reports to Country Trial Managers and clinical

study investigators in the US

- Tracks all reportable case submissions and troubleshoots submission

failure

- Provides feedback to management to improve data entry quality and

minimize submission errors

- Collaborates with Associate Director and Submissions Officers on process

improvement initiatives related to expedited reporting

- Acts as liaison between Regulatory Affairs, Clinical Pharmacology,

Clinical Operations, Global R&D Processes, PV Quality & Compliance and

Systems groups

- Distribute Quarterly Summary Reports (QSR) to Clinical Pharmacology and

Clinical Operations

- E2B submissions of US spontaneous non-serious safety reports of

marketed products to the FDA

- Bookmark and hyperlink PDF Labels and Literature articles, and E2B

through the FDA Gateway

- Daily Monitoring of the US Submissions group mailbox

Business Support Specialist May 2009 - Aug 2011

- Perform daily submissions of IND/NDA safety reports to Regulatory

Affairs.

- Daily Monitoring of E2B reports via Submission Tracking Application to

ensure on time reporting.

- Daily submission of E2B reports (literature and labels) to FDA.

- Perform daily monitoring of Weblog to ensure on time reporting and system

availability.

- Perform daily monitoring of STA to ensure cases have corresponding

approval numbers.

- Daily monitoring of RightFax transmissions to ensure all incoming

information is received and complete.

- Keep daily log of all incoming information to Global Pharmacovigilance

department.

- Daily monitoring of unproduced reports via Variable Report tool.

- First line of contact with all departmental computer issues (100+

employees)

- Daily resolution of minor computer issues throughout department.

- Creation of the Escalation Plan, a road map for Business Support duties.

- Operational Qualification (OQs) for Clintrace Client and Reports

- Betaplus (backlog) files in text format generated via OCR

- QC (Quality Control) of Betaplus (backlog) files.

- Assist with FDA Audits.

- Upload Legal cases for the Medical Records Team

Brinda Idnani Page

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Safety Data Assistant 2008-2009

- Print and distribute adverse event reports received from Rightfax per

department guidelines

- Initial triage and distribution to the Therapeutic areas

- Perform daily reconciliation to ensure all adverse events have been

received

- Write and send queries to MSPW Nurse Program and NexConnect Nurse

Program to clarify missing or incorrect information to ensure accurate

reporting

Johnson & Johnson, Morris Plains, NJ 2004-

2007

Safety Analyst 2006-2007

Responsible for operational and tactical aspect of infrastructure and

system activities and projects within the Global Product Safety

department to ensure that Safety Systems meet global regulatory and

J&J/BRM quality standards

- UAT and UST for Safety applications ARISg, ARCS, and Hyperion.

- Lead for ARCS 5.4 upgrade, training and user manual update

- Business check-out for ARISg involving validation, impact and deployment

activities

- Business check-out for MedDra 10.0 involving validation, impact and

deployment activities

- Business Liaison and Business Admin for Safety Systems

- Project lead on data analysis and report generation for the largest

Pfizer product divestiture project (approximately 17K cases)

- Assist with validation activities including review and performance of

UATs during the $16.6 billion buyout of Pfizer's Consumer HealthCare

- Support data migration of Safety systems for separation of Pfizer Human

Health and Consumer HealthCare.

Pharmacovigilance Assistant 2004-2006

Responsible for coordinating and data entry of preliminary and follow up

case information from source documents into an adverse event database.

- Proficient in case processing of worldwide safety reports. Completed

approximately 6,759 non-serious adverse event cases with narratives, for

NDA & non-NDA products, for medical devices, for USA and foreign

countries.

- Determined labeled status and standard references for concomitant

medications and indication codes.

- Code adverse events and medical history from MedDra dictionary.

- Prepared a medical narrative and generated regulatory reports, CIOMS

and MedWatch.

Self Employed Investor

2002-2004

Analysis of real estate and securities markets, involved in the buy and

sell process. 1996-2000

AT&T, Morristown, NJ

2001

Case Manager in the Corporate Resolution Group responsible for responding

to informal complaints that have been served against AT&T by the Federal

Communications Commission (FCC) regarding all areas of AT&T.

- Managing and directing company resources and coordinating the

investigation of the complaint to final resolution.

- Communication of various corporate issues utilizing strong verbal,

written, interpersonal and negotiating skills meeting customer needs and

ensuring the protection of the AT&T brand.

Hoechst-Roussel Pharmaceuticals Inc., Somerville, NJ

1983-1995

Sales Systems Administrator 1991-1995

Programmed analytical information utilizing sales, prescription and

activity data to increase effectiveness of Market Research Teams, Field

representatives, to develop selling strategies and to monitor trend

analysis. Conducted market place analysis for Brand Teams providing

information to penetrate markets, determine business opportunities and

develop and implement sales motivational programs that supported the

Brand strategy.

Brinda Idnani Page

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- Designed, developed and implemented a unique automated system

transmitting vital information to various departments via e-mail. This

system reduced processing turn-around time from 2-3 days to 5 minutes and

eliminated tedious manual processes used.

- Identified target doctors and participated in an ad campaign for market

research designed to increase prescription market share and to focus

sales representatives' efforts.

- Produced market share analysis reports and monitored prescription and

dollar sales activity determining effectiveness of direct consumer

advertising.

- Calculated and analyzed Managed Care influence references and 3rd party

sales percentages determining suitable managed care prospects.

Contracts Administrator 1986-1991

- Reengineered process of paying out Co-op advertising dollars utilizing

FOCUS programming language, resulting in significant savings in system,

administrative and paper costs. Paper costs alone were reduced from

$2,640 to $100 per year.

- Analyzed promotional programs designed and developed automated database

management systems tracking activity and payments.

- Developed computer programs facilitating the information needs of the

Contracts department reducing excessive consultant fees.

- Responsible for the administration of promotional programs from

receiving and auditing claims to payment disbursements.

Computer Operator 1983-1986

- Operated system consoles and ran jobs scheduled, performed IPL of the

system, responded to network hardware - software failures and operated

the print and tape rooms.

Education: A.A.S in Computer Science, Raritan Valley Community College,

Branchburg, NJ

Technical Skills & Systems

Argus, Clintrace, Citrix, RightFax, Lotus Notes, Submission Tracking

Application, BayLearn, Documentum

Windows 7, MS Office 2010, Internet Explorer 8, Business Objects, MS

Lync, DailyMed, PWP

ARISg - Adverse Reaction Information System (Global), ARCS - Adverse

Reaction Collection & Staging

MSSO MedDRA Dictionary, WHODRUG Dictionary, OpsRadar Archiving System,

Outlook,

Pfizer Corporate Information Life Cycle Management, GXP Part II

compliance guidelines

Company Sponsored Courses

Active Learner SOP, WI, POL. Management Development Seminars, Project

Management, Roadmaps to Problem Solving, Presentation and Facilitator

workshops, Integrity Selling, Effective Communications.

Awards/Recognition

Two Pfish cards received, 1 in 2006 and 1 in 2007

Presidential award in 1995, Quality Recognition Program Achiever in 1994

and 1995

Language Proficiencies: Hindi and Sindhi

Community Activities

- Managed and implemented a Telethon network campaign resulting in

revenues of over $50,000 per year from 1994 to 1999. Consulting and

training provided in 2000.

- Managed and organized 1995 and 1996 Temple Anniversary celebrations for

750 people. Coordinated the various departments' work into action from

inception to finale. Provided consulting and training in 1997.

- Volunteer work done at Hemophilia Walk, June 5, 2011 at Riverside Park

in NYC.

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