Urmi Davda

****, ******* ***,

Apt ***, Carlsbad, CA 92008

abmafz@r.postjobfree.com, Phone: 760-***-****

EDUCATION:

****-****: University of Manchester. UK

MSc Molecular and Medical Microbiology.

Research Dissertation "Screening of heterogeneous Vancomycin

Resistance in MRSA strains across Europe".

2004: Honours Program in "Recombinant DNA Technology" at St.

Joseph's College of Science, Bangalore. Presented a project titled

"CENTRAL DOGMA" for which I was awarded Grade - O (Outstanding).

2001-2004: University of Bangalore. India

BSc Microbiology.

PROFESSIONAL EXPERIENCE:

August 07- October 09 Pharmacovigilance Associate, Johnson & Johnson Ltd,

UK

. Applied knowledge of Volume 9A and ICH GCP in performing daily

pharmacovigilance activities for UK, Ireland and Malta.

. Developed and maintained efficient correspondence with our Global head

office in the USA. All activities within the drug safety department

were carried out as per FDA and MHRA requirements.

. Designed and implemented new systemised working procedures which

helped process serious, non serious adverse events more accurately

within the required timeline.

. Ensured all serious cases were expedited electronically via E2B in a

complaint manner.

. Took a lead role in preparations for internal audits, MHRA and FDA

Inspections.

. Scheduled monthly complaint meetings and expedited monthly reports

which motivated the departments to work together and improve

performance.

. Promoted the importance of data collection and good documentation

practices. Also ensured these were incorporated within the department

and company.

. Introduced and organised trainings for all new Johnson & Johnson

employees which addressed the importance of drug safety.

March 06 - July 07 Clinical Safety Associate, ICON Clinical (CRO), UK

. As a lead on a large number of clinical trials, developed and

implemented study specific procedures (SSP).

. Supervised triage of clinical trial cases, case handling (including

regulatory reports); reviewed patient narratives, expectedness

assessments, validity and integrity of information entered within the

safety databases.

. Conducted weekly and monthly quality checks ensured on-time reporting

of all serious, non serious adverse events, pregnancy reports and

SUSARs.

. Initiated and chaired various project team meetings with other

functional groups involved in the studies. This increased

communication and helped resolve queries spontaneously.

. Some of the areas of clinical trials worked on are CNS &

Transplantation (Roche), Trial to reduce Cardio Vascular Events

(Amgen). Phase III trial on Active Crohn's disease, Phase II double

Blinded Over Active Bladder.

AWARD: Employee Recognition Award 2006, Icon, UK

Award recognised the improvement and transformation brought about

within the department which in turn benefited the company as our

department was able to accommodate more business.

September 05 - March 06 CRF Reviewer, Astra Zeneca, UK

Prostate Cancer Clinical Study, Phase III sNDA Zoladex drug, reviewed

patient's CRF pages and reported unexpected events. Assimilated

information into line listings and worked unsupervised within a small

team.

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RESEARCH EXPERIENCE:

June 2005: Research Assistant, Manchester Metropolitan University, UK (Part

time)

Studied Pax3 gene isomerism and its role in oncogenesis. Gained

expertise in protocol techniques such as tissue culture, cDNA

synthesis, RT PCR, RNA synthesis, western Blot.

Sept 2004: Microbiologist, University of Manchester, UK (Part time)

Mycrograb (immunodominant antigen) was studied using Biacore

Technology and Candida albicans species.

CONTINUING PROFESSIONAL DEVELOPMENT

In-house training courses provided by Johnson & Johnson, Icon, Roche and

Astra Zeneca.

. Pharmacovigilance and Risk Management by MHRA.

. Back to Basics in Pharmacovigilance (DSRU Education and Research

Limited).

. Medical aspects of Adverse Drug Reactions (DSRU Education and Research

Limited).

. MedDRA; Regulatory reporting; ARISg, MedInfoSys, ADVENT, SCEPTRE

safety databases.

. Introduction to Pharmacovigilance (understanding ADR, SAE, Pregnancy

and SUSAR reporting).

. Introduction and understanding Volume 9A.

. Importance of good documentation practices, common audit findings and

inspection readiness.

. Electronic reporting of CIOMS to Regulatory Authorities.

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