Shikha Sharma
Pharmacovigilance Analyst
Mumbai
Summary
Driven and resourceful pharmacovigilance professional experienced in the complete range of industry-related processes including ICSR data input, medical safety document analysis and composition, formulation and execution of standard operating procedures, and corrective action plans.
Overview
12
12
years of professional experience
Work History
Analyst-Pharmacovigilance
TATA Consultancy Services
09.2015 - Current
- Ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision
- Manage safety cases, including case intake/triage, data entry, quality assessment, medical review, and follow-up activities following the global regulatory requirements.
- Assist with projects in a dedicated safety database environment with pharmacovigilance (PV) systems projects.
- Support the team on safety-related issues and submit clinical regulatory responses to the health authorities as required.
- Review, extract and accurately enter AE data from the marketed product, adverse event reports received from - spontaneous and/or solicited and/or clinical trial and/or legal and/or literature sources including health professionals, sales representatives, consumers and drug information in accordance with currently defined case handling procedures
- Interpret case-related information including AE coding, medical conditions, lab results and procedures, as well as compile complete narrative summaries
- Process and prepare re-portable cases within applicable timelines
- Review, enter and verify follow-up information for cases, including correct identification of cases requiring targeted follow up
- Co-ordinate and conduct knowledge sharing sessions for the different type of case scenarios in the team
- Make significant contributions to projects relating to improvements in processes and systems
- Extensive knowledge of medical terminology across a broad range of medical practice areas
- Excellent data entry skills
- Good multitasking abilities
- Strong understanding of ICD-9-CM and CPT requirements and procedures
- Good interpersonal skills and the ability to function as a team member
- Experience with fast-paced medical care environments.
Project Lead
Health Impetus Pvt Ltd
11.2013 - 08.2015
- Distinguish & analyze the ratio of risks & benefits of a drug that is marketed
- Client co-ordination to give the brief about project in terms to therapy adherence, compliance and over all growth on project
- Maintain patients data and documentation to ensure 100 % compliance for all the project
- Co-ordination with field team for daily visit to patient and reports
- Distinguish & analyze the ratio of risks & benefits of a drug that is marketed.
Senior Client Lead
Cryobanks & Diagno Labs Pvt. Ltd
05.2012 - 11.2013
- Worked for client handling for cryobanks an diagno labs
- Resolve various volatile customer situations while maintaining the balance between the interests of the company and customer expectation
- Provide additional inputs to develop sales proposals and collaborate with a company's multiple internal departments to help improve the quality of products
- Maintaining Diagno-Labs & Cryobanks Client service process & providing training to the new joiners
- Provide detailed and accurate accounts of customer calls to ensure compliance to set procedures.
Process Associate
SRL Ltd
12.2011 - 04.2012
- Handling Inbound Voice calls for third party labs
- Handling Data Verification for Third Party labs
- Ensuring Good Customer Service.
Skills
Report Preparation
undefinedEducation Summary
- PGDBA (Ops), Symbiosis Center for Distance Learning, Operations
- B.Sc.(Bio-tech), 2011, Maharashi Dayanand University, Biotechnology
Current Role Description
BPM professional with 10+ years of exposure in Heath and telecom industry- Business Analysis, Requirement Capture and Gap Analysis, As-Is and To-Be Process mapping, Process Consulting and Project Management.
Skill Experience Summary
Around 10+ years’ experience in the multiple domains in different Health care management.
Agile Certified
For PVAI (Pharmacovigilance Artificial Intelligence), conducted user acceptance testing to ensure that developed systems satisfied the needs of business clients as specified in the functional requirements.
Excellent knowledge of ARGUS (Analytical Reports Gathering and Updating System).
Conducting Process Training to new joiners on WHODrug, MedDRA and Product training.
Developed training materials for all levels of personnel involved in pharmacovigilance activities
Participated in internal quality control activities such as audits and training sessions to ensure compliance with applicable regulations/guidelines and company policies & procedures.
Conducted pharmacovigilance (PV) data analysis and interpretation of safety reports to identify potential signals, including adverse event causality assessment; reviewed medical records for accuracy and completeness.
I possess excellent communication, analytical, presentation, negotiation, and relationship management skills with proven ability to build healthy relations with business partners and customers
Passport Details
Shikha Sharma, Self, P5634599, 01/03/17, 02/28/27, Shimla
Technology Experience
Microsoft Office Tools (MS Word, MS Excel, PowerPoint), SQL Basic, One Note, C# language, Agile, Six sigma methodology., Project Management, Presentation skills, Analytical skills, Client relationship management
Personal Information
- Date of Birth: 02/06/91
- Nationality: Indian
Projects
Case processor for Bayer pharma, September 2015 – Present, Bayer Pharma, The objective of this project is monitoring all products and conducts post-market evaluations to ensure drug safety. These experts are actively involved in assessing adverse event writings, updating reports on safety, conducting quality and conveying drug related case reports to appropriate authorities., Ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision.
Review, extract and accurately enter AE data from the marketed product, adverse event reports received from - spontaneous and/or solicited and/or clinical trial and/or legal and/or literature sources including health professionals, sales representatives, consumers and drug information in accordance with currently defined case handling procedures.
Interpret case-related information including AE coding, medical conditions, lab results and procedures, as well as compile complete narrative summaries.
Process and prepare re-portable cases within applicable timelines
Review, enter and verify follow-up information for cases, including correct identification of cases requiring targeted follow up.
Co-ordinate and conduct knowledge sharing sessions for the different type of case scenarios in the team.
Make significant contributions to projects relating to improvements in processes and systems.
Extensive knowledge of medical terminology across a broad range of medical practice areas
Excellent data entry skills
Good multitasking abilities
Strong understanding of ICD-9-CM and CPT requirements and procedures
Good interpersonal skills and the ability to function as a team member
Experience with fast-paced medical care environments Project Lead for Health Impetus Pvt. Ltd, November 2013 – August 2015, Health Impetus Pvt. Ltd, Working in healthcare as a project documents designing and maintaining Project base application development, Distinguish & analyze the ratio of risks & benefits of a drug that is marketed.
Client co-ordination to give the brief about project in terms to therapy adherence, compliance and over all growth on project.
Maintain patients data and documentation to ensure 100 % compliance for all the project
Co-ordination with field team for daily visit to patient and reports
Distinguish & analyze the ratio of risks & benefits of a drug that is marketed. Sr. Client Lead for Cryobanks & Diagno Labs Pvt. Ltd, May 2012 – November 2013, Cryobanks & Diagno Labs Pvt. Ltd, Working in healthcare as a part of development and excellence team, Worked for client handling for cryobanks an diagno labs.
Resolve various volatile customer situations while maintaining the balance between the interests of the company and customer expectation
Provide additional inputs to develop sales proposals and collaborate with a company's multiple internal departments to help improve the quality of products.
Maintaining Diagno-Labs & Cryobanks Client service process & providing training to the new joiners
Provide detailed and accurate accounts of customer calls to ensure compliance to set procedures Process Associate for SRL Ltd, December 2011 – April 2012, SRL Ltd, Working in query resolution for support team, Handling Inbound Voice calls for third party labs
Handling Data Verification for Third Party labs
Ensuring Good Customer Service
Training
- Business Analysis, 2019
- Robotic Process Automation - BluePrism, 2019
- SQL Basic, 2018
- Lean Six Sigma, 2017
Timeline
Analyst-Pharmacovigilance
TATA Consultancy Services
09.2015 - Current
Project Lead
Health Impetus Pvt Ltd
11.2013 - 08.2015
Senior Client Lead
Cryobanks & Diagno Labs Pvt. Ltd
05.2012 - 11.2013
Process Associate
SRL Ltd
12.2011 - 04.2012
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