Quality Six Sigma

Shweta Vinod Gulati Address: ** St Alphonsus Street

E-mail id: *****************@*****.***/ 6th Floor, Flat no. 604

******.*******@*****.*** Boston, MA, 02120, USA

Contact no: Mob: 1-617-***-****

Objective:

To continue to work in a challenging and fast paced environment of today’s world, leveraging my knowledge and fostering creativity, with many 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;

Clinical Research Background

Good communication skill

Teamwork

Attention to detail

Concern for Quality

Basic Voice skills

Initiative

Education:

B. Pharmacy

H(S)NCB’s,

Dr. L.H. Hiranandani College of Pharmacy,

Ulhasnagar (E)

Mumbai University, India.

1st Year: First Class (64.50%)

2nd Year: First Class (63.50%)

3rd Year: First Class (66.06%)

4th Year: First Class (62.42%)

H.S.C. Science.

Mumbai Board, Maharashtra, India.

First Class with Distinction (81.33%)

S.S.C.

Mumbai Board, Maharashtra, India.

First Class with Distinction (79.73%)

Employment Details:

Employed with Cognizant Technology Solutions from Sep2009 to Aug2011.

Client: Largest American research-based biomedical and pharmaceutical leader. (PFIZER)

Responsibility: Case Accessor

Checking the consistency of case against the source document and entering any data found relevant during assessment, Coding 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

Case processing: Processed Clinical Trial cases, Solicited Serious and Non Serious cases, Spontaneous Serious and Non Serious cases. Processed Non Assessed Licensing Partner drugs cases. 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 cases

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.

Auditing and providing feedback to case assessors for the cases they have submitted.

Case processing as and when required in case of spike in case volumes/ aggregate reports submission on due.

Processing expedited cases and query cases.

Analyzing trends, conducting root cause /regression analysis

Documentation of weekly Feedback calls with Mentors/ Pfizer Trainers.

Responsibility: SME (Subject Matter Expert)

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

Identifying and rectifying quality issues for the case generated.

Ensure quality according to SOP

Submission of reviewed cases into client database.

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.

Professional Achievements:

Got 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 & Awards:

Awarded First Prize in “Young Innovator’s Choice Competition” 2007-08 sponsored by Institute Of Chemical Technology, Matunga, Mumbai.

Presentations and Conference attended:

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.

Extra-Curricular Activities:

Participated in Blood donation camp in 2007-08 & 2008-09.

Participated in Math’s Olympiad sponsored by Rotary Club of Ulhasnagar.

Participated in Liberty Association for the Blind and Physically Handicapped for raising the funds during Year 2003.

Participated in Indian Scout and Guide Program.

Extra Skills:

Diploma in Computer Applications from Sterlite Training Institute.

Personal Information:

Date of Birth: May 05, 1988

Gender: Female

Marital Status: Single

Nationality: Indian

Current Address: 75 St Alphonsus Street, Boston, MA 02120, USA.

Contact this candidate