Shweta Vartak

**** ***** ****, *** **, Voorhees, NJ 08043

ab8mzf@r.postjobfree.com

ab8mzf@r.postjobfree.com

Contact No.: 781-***-****

OBJECTIVE:

A highly self-motivated professional seeking a challenging role in

Pharmacovigilance where I can utilize my qualifications and skills towards

accomplishing tasks and grow in my role.

SUMMARY:

. Approx. 4 years of Pharmacovigilance experience as a Drug Safety

Associate for Phase I, II, III and IV studies.

. Experience of working with various US clients as per US FDA safety

reporting regulations (Summary is provided on next page).

. Received Role of Honor for outstanding performance at SIRO ClinPharm.

. Conducted trainings on revised international safety guidelines in the

department at SIRO Clinpharm.

. Successfully faced four sponsor audits without a single finding

regarding Medical/ Safety documentation.

. Extensive knowledge of US and ICH safety reporting regulations and

guidelines.

. Interest and basic knowledge of drug development process, clinical

trial process and clinical development plans.

. Experience with MedDRA and WHO Drug dictionaries.

. Proficient in data entry on drug safety databases (AERS and ARISg).

. Experience with Blinding/ un-blinding of adverse event cases and

generation of regulatory reports on databases.

. Excellent communication skills, both written and verbal.

. Proven interpersonal, organizational skills and analytical thinking.

. Demonstrated ability to adapt quickly, prioritize tasks appropriately

and work as a team.

Skills:

AERS Database, ARISg Database, Microsoft Office, Internet Application

Pharmacovigilance, SOP Development, Business Presentations, Training.

Education:

Advanced Drug Safety Associate

New Jersey State Approved

MBA in Health Care

Sikkim Manipal University

Bachelor of Pharmacy

Bombay College of Pharmacy, Santacruz/ Mumbai University

Professional Employment:

Research Associate Sep 2012 - Present

Qtech-Sol Professional Development Center (QPDC) Inc. - Somerset, NJ

Involved in development of proposed training programs for Drug Safety

Associate as per company's objectives set forth into Learning management

System (LMS) which includes:

1) Introduction to Pharmacovigilance; 2) Introduction to Preclinical,

clinical trials I, II, III, and post marketing;

3) Data Sources: Clinical trials (I, II, III), Solicited Reports, Spontaneous

Reports; 4) Valid Report- Assessing;

5) Invalid case Reports; 6) Medical confirmation of reports; 7) General team

structure;

8) Introduction to Safety Databases; 9) Timelines: Regulatory clock,

Regulatory timelines, internal timelines;

10) Triage; 11) Case creation; 12) Guidelines to enter the data in general:

Receipt date, All case tabs/source information including: Patient, Reporter,

Product, Event, etc. 13) Capturing of Adverse events: AE/ADR;

14) Coding conventions; 15) Seriousness Criteria; 16) Sequencing of Adverse

events: Seriousness, Related;

17) Labeling Guidelines; 18) Causality Matrix & Assessment; 19) Narrative

Templates; 20) Company Medical Evaluation comment; 21) Letters/ Case

Follow-up; 22) Duplicate case handling; 23) IMP/Comparator/Background therapy;

24) SUSAR Reports; 25) Rules & Regulations: ICH Guidelines, FDA; 26) New FDA

guidelines; 27) Audit

Developed case studies of various types of drug safety training programs.

Developed case study documents, forms, scenario examples for student training

as needed for student learning practices applying protocol specifies, SOPs to

build Drug Safety and other clinical research e-Learning (Learning Management

System) programs for online training.

Interacted with USA Qtech professional and Advisor in field, gather

information, synthesize and document them suitable for student learning.

Provided assistance with the preparation of project-related presentations.

Verified the accuracy and validity of data entered in databases; correct any

errors.

Developed and implemented research quality control procedures.

Adhered to timelines and goals as provided before start of the each project

initiatives.

Senior Executive- Pharmacovigilance Jun 2008 - Mar

2012

SIRO Clinpharm USA, LLS (Pharmacovigilance Service Division) - Ewing NJ

Worked as Senior Pharmacovigilance officer to support pharmacovigilance

reporting of various marketed drugs and clinical studies for Roche (Rheumatoid

Arthritis), Incyte (Metastatic Breast Cancer), Rexahn Pharmaceuticals, Inc.

(Metastatic Pancreatic Cancer) and Spherix Inc (Mild Type 2 Diabetes

Mellitus).

Involved in process of implementation, validation and testing of AERS

database.

Prepared User Acceptance Tests (UATs) for any new functions/ tests on AERS

database.

Full involvement in generation of customized E2B report first time on AERS

database.

Prepared reference guide for users to generate E2B reports on AERS database.

Prepared study specific Safety Management Plan, SAE Report Form, Patient

Registration Form and Screening form for recruitment of the patients as per

Protocol.

Performed safety review of clinical data (Case Report Forms) and patient labs.

Involved in SAE Reporting Process: Reviewing of SAE form for legibility and

completeness after receipt of same from the investigator site.

Performed triage for seriousness, relatedness, and expectedness and

prioritized incoming adverse events as per the protocol, investigator

brochure, and/or labeling.

Data Entry, Causality Assessment and Edit submission records for Individual

Case Safety Reports (ICSRs).

Generated well written, concise and accurate narratives for both serious and

non-serious cases.

Medical Record Extraction from Hospital records and Lab reports of the

patient.

Coding of Adverse Events and products as per MedDRA and WHO drug dictionaries

respectively.

Generated Reports - Regulatory submission reports (MedWatch 3500A, CIOMS I,

Clinical Analysis Letter) discrepancy reports and line listings.

Communication with the investigator sites/ Sponsor/ study team personnel to

obtain relevant safety information.

Involved in Expedited Reporting of SUSARs to Regulatory authorities and other

participating sites within the reporting timeframe.

Prepared and maintained trackers to track SAE's, SUSAR's, Ethics Committee's

and regulatory authority's acknowledgements, Lab Reports, Protocol Waivers,

Deviations & Violations.

Involved in preparation of annual safety status report, safety section/ SAE

tabulation of Annual IND Report/ DSUR and PSUR.

Involved in Pregnancy reporting process: Reporting of pregnancies to the

sponsor, follow-up with the sites about the outcome and provide a regular

update to the sponsor.

Assisted in AE-SAE reconciliation process.

Provided end-user as well as admin training to new personnel recruited in the

department.

Involved in preparation of database guidelines and SOPs.

Maintained Drug Safety electronic and hard copy files in-house to ensure

internal audit readiness.

Senior Executive- Pharmacovigilance Feb 2011 (1 Month)

SIRO Clinpharm Germany, (Pharmacovigilance and Drug Safety) -Offenbach,

Germany

Attended training and hands-on experience on ARISg safety database.

Involved in preparation of presentation and material for ARISg safety database

training to India Drug Safety team.

Summary of responsibilities handled for US clients in SIRO Clinpharm LLS:

Client Phase Indication Responsibilities

Roche III Rheumatoid Involved in SAE Reporting Process: Reviewing of

Arthritis SAE form for legibility and completeness after

receipt of same from the investigator site.

Forward the SAE form to Sponsor.

Communication with the investigator sites/

Sponsor/ study team personnel to obtain relevant

safety information.

Involved in Expedited Reporting of SUSARs to

Regulatory authorities and other participating

sites within the reporting timeframe in India.

Prepared and maintained trackers to track SAE's,

SUSAR's, Ethics Committee's and regulatory

authority's acknowledgements.

Involved in Pregnancy reporting process: Reporting

of pregnancies to the sponsor, follow-up with the

sites about the outcome and provide a regular

update to the sponsor.

Assisted in AE-SAE reconciliation process.

Incyte I / II Metastatic Prepared study specific Safety Management Plan,

Breast SAE Report Form, Patient Registration Form and

Cancer Screening form for recruitment of the patients as

per Protocol.

Performed safety review of patient labs.

Involved in SAE Reporting Process: Reviewing of

SAE form for legibility and completeness after

receipt of same from the investigator site.

Performed triage for seriousness, relatedness, and

expectedness and prioritized incoming adverse

events as per the protocol, investigator brochure,

and/or labeling.

Data Entry, Causality Assessment and Edit

submission records.

Coding of Adverse Events and products as per

MedDRA and WHO drug dictionaries respectively.

Generated well written, concise and accurate

narratives.

Generated regulatory submission reports (CIOMS I,

Clinical Analysis Letter).

Communication with the investigator sites/

Sponsor/ study team personnel to obtain relevant

safety information.

Involved in Expedited Reporting of SUSARs to

Regulatory authorities and other participating

sites within the reporting timeframe in India.

Prepared and maintained trackers to track SAE's,

SUSAR's, Ethics Committee's and regulatory

authority's acknowledgements, Lab Reports,

Protocol Waivers, Deviations & Violations.

Involved in preparation of annual safety status

report, safety section/ SAE tabulation of Annual

IND Report.

Assisted in AE-SAE reconciliation process.

Maintained Drug Safety electronic and hard copy

files in-house to ensure internal audit readiness.

Rexahn IIa Metastatic Prepared study specific Safety Management Plan,

Pharmaceut Pancreatic SAE Report Form, Patient Registration Form and

icals, Cancer Screening form for recruitment of the patients as

Inc. per Protocol.

Performed safety review of clinical data (Case

Report Forms) and patient labs.

Involved in SAE Reporting Process: Reviewing of

SAE form for legibility and completeness after

receipt of same from the investigator site.

Performed triage for seriousness, relatedness, and

expectedness and prioritized incoming adverse

events as per the protocol, investigator brochure,

and/or labeling.

Data Entry, Causality Assessment and Edit

submission records.

Coding of Adverse Events and products as per

MedDRA and WHO drug dictionaries respectively.

Generated well written, concise and accurate

narratives.

Generated regulatory submission report (MedWatch

3500A).

Communication with the investigator sites/

Sponsor/ study team personnel to obtain relevant

safety information.

Involved in Expedited Reporting of SUSARs to

Regulatory authorities and other participating

sites within the reporting timeframe.

Prepared and maintained trackers to track SAE's,

SUSAR's, Ethics Committee's and regulatory

authority's acknowledgements, Lab Reports,

Protocol Waivers, Deviations & Violations.

Involved in preparation of annual safety status

report, safety section/ SAE tabulation of Annual

IND Report.

Assisted in AE-SAE reconciliation process.

Generated patient narratives and other safety

requirements for DSMB meetings.

Maintained Drug Safety electronic and hard copy

files in-house to ensure internal audit readiness.

Spherix II Mild Type Involved in SAE Reporting Process: Reviewing of

Inc. 2 Diabetes SAE form for legibility and completeness after

Mellitus receipt of same from the investigator site.

Forward the SAE form to Sponsor.

Communication with the investigator sites/

Sponsor/ study team personnel to obtain relevant

safety information.

Assisted in AE-SAE reconciliation process.

Communication with the investigator sites/

Sponsor/ study team personnel to obtain relevant

safety information.

Prepared and maintained trackers to track SAE's,

SUSAR's, Ethics Committee's and regulatory

authority's acknowledgements, Lab Reports,

Protocol Waivers, Deviations & Violations.

Assisted in AE-SAE reconciliation process.

Maintained Drug Safety electronic and hard copy

files in-house to ensure internal audit readiness.

References will be provided on request

Contact this candidate