K arishma Desai

* ** ******* ** ** *, Clifton, NJ acdgn0@r.postjobfree.com (973)356-91

SUMMARY

Seeking a position of pharmacovigilance scientist to utilize my interest, credentials and 6+ years of experience in th

medical field.

CORE COMPETENCIES

Comprehensive knowledge of international drug safety and pharmacovigilance processes, procedures, princ

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and regulations.

Vast experience working with s afety databases like- agXchange, ARISg (6.3 and 6.6) a nd Advent.

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

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Effective communication and networking skills.

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Trained in RCA and yellow belt certified.

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Knowledge of aggregate clinical safety regulatory reports such as PSURs, ASRs and signal detection.

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Good exposure of working with MS Office (Word, Excel, Powerpoint, Access).

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EXPERIENCE

Sep 2009 – Dec 2013

Process Lead/Pharmacovigilance Scientist Level II

Tata Consultancy Services – Drug Safety, Mumbai, India

For 4+ years at TCS - Mumbai, served our client - H offmann-La Roche Ltd, a S wiss based g lobal health-c

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company, a s a Pharmacovigilance Professional.

Responsible for case initiation, case processing, case triaging, medical coding, monitoring productivity trac

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and narrative drafting within challenging turn-around times while maintaining quality matrices.

Excellent knowledge of case coding, inactivating, narrative writing as per ICH-GCP: G CP 2461 and GCP 1

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Well versed with medical terminologies and M EDRA c oding dictionary.

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Experienced in handling variety of cases; including Clinical (serious and non-serious), Non-Interventional,

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S pontaneous, Line listing, Pregnancy cases per client’s SOP’s and GCP’s.

Coordinated the SAE reconciliation on a continuing basis for safety and clinical databases.

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As a PV Process SME, provided leadership to Drug Safety Associates through all phases of ICSR processin

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activities.

Ensured punctuality and timeliness in the collection, processing and regulatory reporting of SAEs. Coordina

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inactivation and deletion activities to ensure that all due cases within this work flow were identified and clo

both agXchange and ARISg databases.

Have prepared and delivered process related training programs (using Powerpoint and Word) for new update

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refreshers to entry-level as well as experienced drug safety associates.

Acted as backup for managers in leading safety reporting aspects.

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Communicated with PV medical team to provide medical evaluation and case assessments. Also communica

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with Investigators, Safety Scientists and SAE affiliates on safety information and issues.

Communicated and collaborated with all functional groups involved in the management of PV process inclu

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clients, safety CROs and external data management vendors.

Represented the company in Drug Safety Operations forums and participated in Study Management Teams.

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Medical Analyst Jun 2008 – Sep 2009

Medusind Solutions, Mumbai, India

D ealt with coding and updating the UNSPC database of a hospital’s supply change management in MS Access data

H ealth Advisor for Public Health Camps Feb 2008 – Nov 2009

G oldsheild Healthcare Pvt. Ltd. Mumbai, India

Duties included history taking, clinical examination and tertiary care of patients especially with joint problems and

obesity

EDUCATION

Academy of Clinical Excellence, Mumbai University – Mumbai, Aug 2008 – Mar 2009

Post Graduate Diploma in Clinical Research

Maharashtra University of Health Sciences, India Jul 2002 – F

Bachelors in Homeopathic Medicine and Surgery (BHMS)

References available on request.

Contact this candidate