Safety Physician Assistant

SWARNA LATHA IPPAKA

** * ******* **, ******, NJ - 08817 480-***-**** ************@*****.***

Objective

With my strong medical background, and bachelor’s degree in life sciences, I have a thorough understanding of the basic concepts of drug safety and risk management, the process of drug development and its life cycle in the open market either as patent or generic drug. The exposure which I have helps me to understand and appreciate the various types and grades of adverse events.

With my excellent academic knowledge I have the capability to correlate the adverse event with any vital and systemic abnormality resulting from the event, and understand the causal relation of the drug which causes Adverse Drug reaction (ADR). I believe, I have focus on the regulatory issues across global governmental agencies like the FDA (Food and Drug Administration); EMA, ICH (International Conference on Harmonization) and others that improve safety.

With my fast learning capabilities and your kind guidance I will gain excellence in areas such as global regulatory and compliance processes, navigation of drug safety for product longevity, management and analysis of drug safety data in the high demand drug safety and phamacovigilance sector.

By doing internship under your supervision I can prepare myself for the demands of highly specialized skill set for managing global drug safety and phamacovigilance for commercial development of drugs and diagnostic technologies.

I want to equip myself and develop an advanced knowledge of the roles and responsibilities of various functionaries in drug safety departments, such as QPPV (qualifies person for phamacovigilance), drug safety physician, drug safety data analyst, drug safety associate, drug safety triage office drug safety auditors and others.

I am very much interested in practicing the processes of triage, data entry, medical review, statistical analysis, implementation of REMS (risk evaluation and mitigation strategy), phase IV surveillance trials, regulatory writer for labels and phamacovigilance strategy.

Education

May 2003 – Apr 2009

Bachelor of Medicine and Bachelor of Surgery (M.B.B.S)

Completed progressive training in basic life sciences diagnosis, treatment and

Handling the diagnosis, treatment of patients.

Ability to demonstrate about prescription and Drugs.

Good writing and communication skills for scientists, GSL, India.

Good knowledge of clinical practices and protocols.

Biomedical Research Methodologies at GSL College, India.

Extremely motivated towards carrier.

Quick and adaptive learner.

Hard working abilities.

Apr 2000 – May 2002

High School study from reputed college with excellent academics 8.9 / 10 GPA with specialization in Botany, Zoology, Physics and Chemistry.

Part of academic project conducted research studies, data gathering and preparing summary reports.

Conducted laboratory tests for statistical data.

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