Quality Management

Shweta Gulati

Shweta Vinod Gulati Address: ** Westland

Avenue, Apt 15

E-mail id: ******.*******@*****.*** Boston, MA, 02115.

Contact no: Mob: 617-***-****

OBJECTIVE

To continue to work in a challenging and fast paced environment of today’s world,

leveraging my knowledge and fostering creativity, with my learning opportunities.

KEY SKILLS

Ability to direct complex projects from concept to fully operational status

Goal Oriented with Strong Leadership capabilities

Organized, highly motivated, detail directed problem solver including;

Pharmacovigilance Background

Good communication skill

Teamwork

Attention to detail

Concern for Quality

Basic Voice skills

Initiative

Multi-tasking

Analytical skills

Writing skills

Time-management

EDUCATION

Masters in Regulatory Affairs

Northeastern University Sep 2011-

April 2013

• Knowledge of GxPs (GCPs, GLPs, GMPs), Electronic submission techniques, types

and requirements of Clinical research, clinical operations, nonclinical and quality

requirement

• Understanding of drug development and biological process and regulatory process in

drug development and biologic development

• Knowledge of Investigational Device Exemptions, Pre-market Approval, 510(k)

application process, and Product Development Protocol development and review

processes for U.S., Europe and Japanese Medical devices

• 510 (k) and PMA submissions for hypothetical medical device

• Registration, submission and strategic planning of regulatory pathway for Japanese

Medical devices and European Medical devices.

Shweta Gulati

• Understanding of FD&C Acts laws, regulations and guidelines

• Interpret and analysis of FDA laws and regulations on a case-by-case basis

• Familiar with the U.S. and global safety regulations, as well as related guidance from

FDA, ICH, WHO, and CIOMS

• Knowledge of FDA, EMA, and other regional reporting requirements and format

• Understanding of European regulatory process, Conformity Assessment Procedures

and Quality System Requirements

• Understanding of the registration principles of biotechnology derives products and

Orphan products

• FDA certification on completion of FDA eCTD Overview and Submission

Bachelor’s Pharmacy, H(S)NCB’s, Dr. L.H. Hiranandani College of Pharmacy, Mumbai

University, India. (Aug 2009)

H.S.C. Science, Mumbai Board, Maharashtra, India. (June 2005)

S.S.C., Mumbai Board, Maharashtra, India. (June 2003)

Diploma in Computer Applications from Sterlite Training Institute.

Employment Details:

Genzyme May 2013-

Present

Pharmacovigilance Compliance Specialist

In the liable business area pertaining to compliance monitoring of timelines for

processing/regulatory reporting of safety reports, the primary function of the PV compliance

specialist role is to:

• Contribute to the development, production and maintenance of the appropriate tracking

and compliance tools, reports, plans, tasks and activities pertaining to the management of

the GPE compliance management system.

• Perform investigation of deviations and monitoring of Corrective actions & preventive

actions (CAPA) relating to noncompliance issues and findings and propose appropriate

long-term strategies to line management.

• Perform compliance analysis and Contribute to development, production and maintenance

of adequate reporting methods to the hierarchy to detect and monitor any significant

compliance deviations to the company quality standards and/or regulatory requirements

• Track and communicate on compliance

• Ensure tasks and activities are performed according to the work instructions, procedures

and Policies in place.

• Contributes as an author or a reviewer to GPE Quality Documents developed within the

Company and relating to compliance monitoring.

• Interface with internal and external stakeholders and ensure that the appropriate contact

points are established with the other groups (within Quality, Training & Compliance or

Shweta Gulati

outside) to respond and address gaps or compliance issues that need resolution by team

specialists.

• Support Affiliates on compliance matters as required

• Support the conduct of PV audits/regulatory inspections

• Participate to the Development of compliance programs and quality tools to enhance GPE

global quality and adherence to SOPS and Regulations.

• Escalate issues / problems to management

Cognizant Technology Solutions Sep 2009 – Aug

2011

Case Assessor

Performing the compliance review of Individual Case Safety Reporting against the

•

source document and entering any data found relevant during assessment

Coding of adverse events, indications and patient history based on MEDRA, Coding

•

of suspect products as well as concomitant drugs using CDD and WHO

Narrative writing for Initial and Follow up cases, Performing Labeling and listedness

•

of events

Generating follow up information if required, assessing the validity of case.

•

Using applications like Argus, eCTD, GDMS etc

•

Individual Case Safety Reporting of Clinical Trial cases, Solicited Serious and Non

•

Serious cases, Spontaneous Serious and Non Serious cases. Processed Non Assessed

Licensing Partner drugs cases received from all the sources as per regulatory

guidelines.

Book In and Data entry and cases processing of Unstructured AEM form cases in

•

Argus.

Processed cases for 11 different Therapeutic areas. Major Teams: CV, Neurosciences,

•

Social Medicines, Hormonal team, Urology and Sexual health, Psychiatry and

Mental Health.

Processed safety reports of US cases and Non US cases reported globally.

•

Duplicate search for safety report cases in Argus.

•

Peer Review of General and Clinical trial case

•

Authenticate accuracy of Adverse Event, Product Complaint cases as per the

•

Standard Operating procedure/AURG Guidelines.

Review any queries regarding the Individual Case Safety Reports

•

Verify capture of any Adverse Event/ Coding/ Listedness / Generating correct follow

•

up letters/ Narratives in Argus.

Submitting documentation relating to Adverse Events to next work flow

•

appropriately.

Processing expedited cases and query cases.

•

Analyzing trends, conducting root cause /regression analysis

•

Documentation of weekly Feedback calls with Mentors/ Pfizer Trainers.

•

Served as SME (Subject Matter Expert)

In addition to the above responsibilities the following responsibilities were added:

Quality Review of Individual Case Safety Reports.

Ensure quality according to SOP

Submission of reviewed cases into client database.

Shweta Gulati

Maintaining agent wise quality and performance records.

Identifying area wise quality and performance records.

Identifying areas of concern for agent quality (individually) by tracking defects,

taking feedback sessions for the agents, performing RCA-CAPA for the defects and

providing details to the team leaders.

Case processing as and when required in case of spike in case volumes/ aggregate

reports submission on due.

PROFESSIONAL ACHIEVEMENTS

Promoted as full time QC reviewer from Case assessor as consistent quality, and

quantity was provided along with good process knowledge.

Lean Six Sigma Certified

Completed Six Sigma Yellow belt and Green belt training

ACADEMIC ACHIEVEMENTS AND AWARDS

Awarded First Prize in “Young Innovator’s Choice Competition” 2007-08 sponsored

by Institute Of Chemical Technology, Matunga, Mumbai.

PRESENTATIONS AND CONFERENCES

Participate and presented poster in” National Conference on Challenges for the

Pharmaceutical and Biotechnology Industries” S.I.E.S. College of Management

Studies, Nerul, Navi-Mumbai.

State Level Poster Presentation Competition “INDIRA PAHARMA ZEAL” At Indira

College of Pharmacy, Pune.

Participated in Young Innovator’s Choice Competition, 2007-08 & 2008-09 UICT,

Matunga, Mumbai.

Inter Collegiate Competition On “Invention Project Of Young Pharmaceutical

Scientists” 2006-07 & 2007-08 at Saraswati Vidya Bhavan’s College Of Pharmacy,

Dombivli.

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