Safety Data Entry
Resume:
Shweta Vartak
**** ***** ****, *** **, Voorhees, NJ 08043
**************@*****.***
**************@*****.***
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