MEGHA BUDHIRAJA

*** ***** **, ***. ***, Waltham, MA-02452

Phone: 667-***-****, Email: acv67s@r.postjobfree.com EDUCATION

University of South Florida, Tampa, FL (U.S.) Aug 2014-May 2016 Masters of Public Health: Public Health Education, GPA: 3.45/4.0 Relevant coursework: Epidemiology, Biostatistics, Social & Behavioral Sciences, Health Policy, Environment Sciences, Health Education Intervention Methods, Evaluation and Research Methods. Catalyst Clinical Services, New Delhi (India) Oct 2011-Mar 2012 Professional Diploma in Clinical Research (6 months) PDM College of Pharmacy, MDU Haryana (India) Aug 2007-May 2011 Bachelor of Pharmacy, GPA: 3.94/4.0

SUMMARY OF SKILLS

Good knowledge of international drug safety and FDA reports and regulatory requirements.

Strong knowledge of FDA, EMA, ICH safety reporting regulations and GCP guidelines.

Experience in monitoring serious adverse events & reports, signal detection and evaluation.

Knowledge of US and EU regulatory requirements and Clinical Trials Phases I-IV.

Experience in reporting post-marketing adverse events and participated in audit preparations.

Experience in Data Cleaning activities in (ARGUS and ARISg) databases.

Preparation of periodic safety reports (eg. PSUR, PADER) for submission to regulatory authorities.

Software: Microsoft Office Suite (Excel), ARGUS Safety Database, ARISg Safety Database, Easy Trak Database, SAS.

PROFESSIONAL EXPERIENCE

University of South Florida, Tampa, FL (U.S.)

Teaching Assistant-Department of Undergraduate Studies Jan 2015-May 2016

Worked as a Teaching Assistant for undergraduate students for Sports Nutrition course. NON-PROFIT ORGANIZATION May 2015-Apr 2016

PROJECT STARFISH, Tampa, FL (U.S.)

Project Intern

Key Deliverables: Questionnaire, Risk factors identification, Diabetes Management Program proposal.

Working with ‘Project Starfish’ a non-profit international organization that collaborates with healthcare providers in Southern India to provide general medical care to rural population for

‘Type II Diabetes Mellitus’.

Responsible for researching risk factors after screening of patients and performed data analysis using SAS.

Evaluated lifestyle and diet of diabetic patients and proposed a Diabetes Management Program.

Evaluated various risk factors involved in the incidence and prevalence of Diabetes.

Completed IRB applications for human subject research study. APCER Pharma Private Ltd. New Delhi (India)

Pharmacovigilance Associate Feb 2013-July 2014

Key Deliverables: Triaging reports, causality assessments, quality review (QC), reporting, narrative writing, weekly progress reports, tracking of case close out activity.

Handled spontaneous reports received from physicians/consumers and clinical safety queries.

Performed case processing/data entry of adverse events reports and verification of serious post marketing adverse events into ARISg database.

Performed Quality review (QC) of Individual Case Safety reports (ICSRs) in Pharmacovigilance database (ARISg).

Clinical review and causality assessments of all reportable Serious Adverse Event (SAE) reports.

Medical & Safety narrative writing of serious & non-serious adverse event reports in ARISg database.

Triaged, distributed and assigned ICSRs to case processors.

Maintained and managed serious adverse event (SAE) tracker for reportable and non-reportable spontaneous reports on daily basis.

Collected verbal and written communication from health care professionals such as physicians as well as from patients for post-marketing of serious adverse events experiences.

Handled suspected unexpected serious adverse events (SUSAR’s) and processed clinical trails reports.

Performed electronic and manual archival including stamping of spontaneous source documents.

Processed adverse event information and assisted in case follow up activities from healthcare professionals.

Reported serious adverse events reports, which require expedited reporting to the regulatory authorities to ensure compliance with regulations.

Liaised, communicated effectively and maintained excellent relationship with the clients and internal/external contacts.

Mentored/trained new hires and conducted team meetings pertaining to spontaneous reports. Ranbaxy Laboratories Ltd. Gurgaon (India)

Medical Affairs and Clinical Research Department (MACR) Pharmacovigilance Project Trainee May 2012-Nov 2012

Key Deliverables: Checked duplication of reports, identified events from various literature reports, causality assessments, adverse event coding and resolved product complaints.

Responsible for the receipt, tracking of duplicate cases and case processing in ARGUS safety database within well-defined time frames, in compliance with standard operating procedures and regulatory requirements.

Assessment of literature case reports received from US for seriousness, causality with inputs from medical reviewer and use of MedDRA (Medical dictionary for regulatory activities) to code medical terminologies (Electronic and Medical coding).

Medical/Safety narrative writing of adverse event reports, labeling, expectedness, reporting and causality assessments.

Processed clinical trial cases, pregnancy cases and literature cases in ARGUS database.

Reported serious adverse events case reports on expedited basis to regulatory authority (FDA).

Experienced in electronic submissions to FDA and other reconciliation activities

Managed and processed Product Quality complaints (PQC)/queries in Easy Trak Database and data cleaning activities.

Database & literature searches using Pubmed and generated CIOMS/MedWatch for submissions.

CAPA management, tracking deviations and report scheduling to ensure compliance. CAMPUS AND COMMUNITY INVOLVEMENT

Arranged AIDS awareness campaign at Ranbaxy’s Annual Event

Volunteered with National Association for Blind Women, New Delhi

Certification of participation in IPGA WELFARE TRUST sponsored seminar on “Advances in clinical research and drug discovery’’

Certification of Divine Social Welfare Society in the event ‘’Stop AIDS Protect the Innocent’’.

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