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Medical Safety

Location:
Mumbai, Maharashtra, India
Salary:
7-8 lac
Posted:
June 05, 2020

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Resume:

CURRICULUM VITAE

Full Name : Bhamini Suresh Thakar

Phone No: 986-***-****/913-***-****

E-mail id: addmde@r.postjobfree.com

CAREER OBJECTIVE

Seeking a challenging and growth oriented position in the Pharmaceutical field and also maximizing professional accomplishment for self-development & organization development.

Always ready to learn new things

To be part of a professional firm holding a responsible & challenging position where I can utilize my knowledge, creativity and abilities ensuring credible performance and hard work with honesty, leading to growth of the organization.

To obtain a position that will enable me to use my strong organizational skills, educational background, and ability to work well with people.

ACADEMIC QUALIFICATIONS

Exam passed

Institutions

Board/University

Year of Passing

CGPA(out of 10)/Percentage

Class/Grade

Final Year B.Pharm

Dr Bhanuben nanavati college of pharmacy Vile parle (W)

MUMBAI UNIVERSITY

2013-14

61.2%

Ist class

H.S.C

T.P Bhatia College Of Science, Kandivali(W)

MAHARASHTRA

BOARD

FEB 2009

70%

Ist class

S.S.C

Aspee nutan vidya mandir malad (W)

MAHARASHTRA

BOARD

MAR 2007

76%

Ist class-DISTINCTION

PROFESSIONAL EXPERIENCE

Organization: TATA Consultancy Services (TCS), Mumbai.

Duration: 17-Nov-2014 to till date.

Designation: Pharmacovigilance Scientist (PVS I)

• Serious Adverse Event (SAE) and Non-Serious Adverse Event Report Processing.

• Review and process serious adverse events, spontaneously reported adverse reactions and/or other medical related information per assigned tasks and study specific procedures.

• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining process file.

• Perform initial evaluation of reported adverse events (non-serious and serious) from all the sources.

• Performs case entries and verification of reported adverse events, enter the information in Argus safety database on the basis of individual case histories from correspondence affiliates.

• Processing Suspected Unexpected Serious Adverse Reaction (SUSAR) cases in clinical studies, strictly compliant to 7-Day and 15-Day timelines.

• MedDRA coding and Narrative writing, processing different cases like E2B. Ensure accurate and consistent coding of events of non-serious and serious adverse event cases in Argus by using MedDRA coding conventions.

• Evaluate causality, seriousness and Listedness for all cases.

• Perform the tasks of maintaining the safety database and perform coding of diseases as well as adverse events according to the project-specific coding conventions.

• Assuring medically cohesive narrative with completeness and accuracy.

• Assessing causality and expectedness of adverse events as per documents like IB, CDS.

• Adverse event (AE) coding by MedDRA browser and drug coding by WHO-DD browser, working on ARGUS 8 safety database, Coding events, indications and patient history based on MedDRA.

• Perform Medical record extraction of litigation and legal (attorney) documents.

• Perform duplicate search of cases and doing LAM entry of the same

• Assists with training/mentoring newly hired associates. Act as a buddy for colleagues and provide training as required.

• Participated in inspection and audits.

• Has served in organisation in following roles

Case processor

Quality Reviewer

CRO LAM officer

Medical record extractor

TECHNICAL SKILLS

• Data analysis and management in MS EXCEL and MS WORD.

• Skilful in application of knowledge to research reports.

DOMAIN SKILLS

• Clinical Research & Pharmacovigilance Domain Awareness.

• Knowledge on drug development (Phase I -IV) of clinical trial.

• Expedited case and its reporting time lines.

• Regulatory guidelines and same time following strict timelines and Knowledge of medical terminology

STRENGTHS

1. Team spirit &Positive attitude.

2. Love to explore &learn new things.

PERSONAL PROFILE

Full name: Bhamini Suresh Thakar

Father’s Name: Suresh Dhirajlal Thakar

Address: E/102, Akshardham blg, opp Toyota showroom, link road, Rajan Pada Malad (west) Mumbai 400064

Contact No: 098********

E-mail : addmde@r.postjobfree.com

Nationality: INDIAN

Date of Birth: 05 January 1992

Gender: Female

Marital status: Single

Languages Known: English

Hindi

Marathi

Guajarati

Hobbies: into fitness and sports

DECLARATION

I hereby declare that the information furnished above is true to the best of my knowledge.

DATE:

SIGNATURE:



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