Data Analyst Pharmacovigilance, Drug Safety

Dr. V. Suresh Subramanian, B.D.S.

Summary of Professional experience:

Dentist with progressive work experience in clinical practice accounting for 8 years, and nonclinical work experience of 7.5 years, previously worked as Senior Drug Safety Associate in Pharmacovigilance at Accenture Software Solutions Limited, Chennai from June 2010 to November 2015, then worked as Medical Coder at IKS Healthcare Solutions, Mumbai from Jan-2020 to Oct-2021 and currently working as Data Analyst in Pharmacovigilance at Cognizant Technology Solutions, Mumbai from March 2022 to February 2024.

Professional Expertise/Strengths:

Have experience in processing spontaneous, solicited, literature, clinical study, and post-marketing pharmacovigilance reports.

Good experience in processing of ICSR’s originating from different sources. Good knowledge and experience in utilizing and handling MedDRA and WHO drug dictionary.

Good knowledge on electronic submissions including submissions of ICSRs. Good knowledge on Argus safety database.

Good knowledge on USFDA guidelines and ICH guidelines. Good knowledge and ability to handle reconciliation for Market Research, Business Partners, Product Quality Complaints, and Partner Market reconciliations. PROFESSIONAL EXPERIENCE:

Data Analyst – (ICSR Reports and Reconciliation):

Cognizant technology solutions – Mumbai

March 2022 to February 2024

Job description:

Access the designated e-mail box(es) to retrieve new incoming safety information or follow-up correspondence for existing Cases regularly and at least three (3) times per shift and spread out over the course of each shift, Store all ICSRs electronically on the agreed shared drive or E-room according to workflow SOP or Guidelines.

Contact the Functional Lead to obtain an English translation, in the event Cognizant receives information in another language than English Send in respect of any safety information, Cognizant pursuant to paragraph, an acknowledgment of receipt (including the Case number) to the Source Document sender in accordance with Guidelines and SOPs.

After book-in of cases, review all forms and documents pertaining to a case for errors, missing information, legibility.

Encode verbatim terms using MedDRA for patient history, product indication, death information screen, and event term information.

Responsible for writing narrative summaries on reported adverse event cases. Responsible for completing the adverse event case; and sending the updated and related documents or information to Medical Review Physician. Perform daily responsibilities in accordance to applicable Standard Operating Procedures (SOPs), conventions and policies.

Totally safety reviewed more than 20000 adverse event reports. Access the designated e-mail box(es) to retrieve new incoming reconciliation information or follow-up correspondence for existing recons regularly. Store all the correspondence emails electronically on the agreed shared drive or E- room according to workflow SOP or Guidelines.

Responsible for completing the reconciliation listings; and sending the updated and related documents or information in a timely manner. Capable of independently handling the Business Partner, Product Quality Complaints and Market Research reconciliations.

Medical Coder – CPT and ICDs:

IKS Healthcare Solutions, Mumbai

06-Jan-2020 – Oct-2021

Have experience in HCC and Inpatient Coding.

Good knowledge in CPTs and ICDs Medical Coding.

Good knowledge in handling electronic Health Record (EHR) platform (CERNER and EPIC).

Good Adherence to HIPPA policies.

Handling Critical Care Coding for Pulmnology, Internal Medicine, Nephrology and Wound Care.

Attending the appropriate process oriented training modules. Good knowledge on electronic submissions of patient medical records as Virtual Scribe. Dental Surgeon:

Sri Ashwini Dental Clinic,

Chennai, Tamil Nadu.

01-Dec-2015 to 31-Dec-2019

Job description:

Diagnosis and Treatment of oral diseases (own clinical practice) Senior Drug Safety Associate:

Accenture Services Pvt. Ltd

Chennai, Tamil Nadu.

Jun-2010 to Nov-2015

Job description:

Access the designated e-mail box(es) to retrieve new incoming safety information or follow-up correspondence for existing Cases regularly and at least three (3) times per shift and spread out over the course of each shift, Store all ICSRs electronically on the agreed shared drive or E-room according to workflow SOP or Guidelines.

Contact the Functional Lead to obtain an English translation, in the event Accenture receives information in another language than English Send in respect of any safety information, accessed by Accenture pursuant to paragraph, an acknowledgment of receipt (including the Case number) to the Source Document sender in accordance with Guidelines and SOPs. After book-in of cases, review all forms and documents pertaining to a case for errors, missing information, legibility.

Encode verbatim terms using MedDRA for patient history, product indication, death information screen, and event term information.

Responsible for writing narrative summaries on reported adverse event cases. Responsible for completing the adverse event case; and sending the updated and related documents or information to Medical Review Physician. Perform daily responsibilities in accordance to applicable Standard Operating Procedures (SOPs), conventions and policies.

Totally safety reviewed more than 10000 adverse event reports. Dental Surgeon:

Sri Ashwini Dental Clinic,

Chennai, Tamil Nadu.

Oct-2005 to 30-Jun-2010

Job description:

Diagnosis and Treatment of oral diseases (own clinical practice) Educational Qualifications:

Course Specialization School/college Board/

University

Year of

Passing

B.D.S Dentistry

Mahatma Gandhi Dental College

and Hospital, Pondicherry.

Pondicherry Central

University

2003

12th

Science

With Maths

Kendriya Vidhyalaya No. 1,

Pondicherry

CBSE

1995

10th CBSE

Kendriya Vidhyalaya No. 2,

Pondicherry

CBSE

1993

Personal Profile:

Name: Dr. V SURESH SUBRAMANIAN

Father’s name: M. VALLARAMAN

Date of Birth: 30 December, 1975

Gender: Male

Marital Status: Single

Mailing Address: 401-B, Fourth Floor,

Sai Kush Apartments, Sector 30, Rabale

Navi Mumbai.

City: Mumbai.

Mobile: +91-960*******

Email Address: **********@*****.***

Alternate mailed: *********@*****.**.**

Languages known: English, Tamil & Hindi.

Declaration:-

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

(Dr. V. Suresh Subramanian).

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