Jagruti Varma
Drug Safety Associate
Pune
Summary
To achieve maximum knowledge in the diverse sectors of pharmacy by working an organization, this can utilize professional skills and knowledge at the optimum level. Seeking a challenging role that allows to utilize expertise in monitoring adverse drug reactions, conducting risk assessments, and contributing to the continuous improvement of process. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
4
4
years of professional experience
7
7
years of post-secondary education
Work History
Drug Safety Associate
Tata Consultancy Services (TCS)
04.2023 - Current
- Promptly and accurately identify, interpret and extract adverse events and all relevant information corresponding to the case, from a wide variety of source documents
- Enter the extracted information into global database for serious and non-serious AE/ADR case reports
- Adhere to Company internal data entry standards and specific timelines, as prescribed by global regulations
- Create and review comprehensive medical case narratives regarding the reported information received
- Verify that trade names are correctly translated into INN (International Non- proprietary Name) as prescribed by regulatory guidelines
- Perform accurate coding of incoming serious and non-serious adverse events and other case information, using MedDRA terminology.
- Perform assessment of cases as per the Global listedness.
Quality Reviewer
Tata Consultancy Services (TCS)
06.2021 - Current
- Vigilantly check for quality of the case related data extracted in to global database, including case narratives and event coding, using MedDRA terminology
- Review cases for the accuracy of data, recorded drug-event relationship and overall case assessment
- Provide timely feedback to associates and document those feedbacks
- Adhere to Client prescribed quality standards and specific timelines
- Identify and analyze the root cause of common errors and reinforce the updates and quality requirements as to mitigate those errors
- Regular follow ups with client on the quality status and improvement.
Patient Safety Associate
Tata Consultancy Services (TCS)
Pune
06.2020 - Current
- Initial and Follow-up information for individual adverse event case reports of the global patient safety
- Implemented data interpretation, coding and writing skills accordance with the current Data entry process as per guidelines of Pharmacovigilance
- Instructions and better understanding of CIOMS, Health Canada cases, European union regulation and guidelines, and good clinical PV Practices.
Education
M. Pharm in Quality Assurance -
JSPM’ Rajarshi Shahu College of Pharmacy And Research Pune
Pune 08.2017 - 07.2019
B Pharmacy -
Savitribai Phule University Pune
Sonai 06.2014 - 06.2017
H.S.C -
Jawahar Madhyamic Vidyalaya,
Chanda 04.2011 - 02.2012
S.S.S -
Jawahar Madhyamic Vidyalaya,
Chanda 02.2009 - 03.2010
Skills
Hard working
undefinedPersonal Information
- Date of Birth: 04/13/95
- Gender: Female
- Marital Status: Single / unmarried
Disclaimer
I do here by declare that the above written particulars are true and correct to best of my knowledge.
Timeline
Drug Safety Associate
Tata Consultancy Services (TCS)
04.2023 - Current
Quality Reviewer
Tata Consultancy Services (TCS)
06.2021 - Current
Patient Safety Associate
Tata Consultancy Services (TCS)
06.2020 - Current
M. Pharm in Quality Assurance -
JSPM’ Rajarshi Shahu College of Pharmacy And Research Pune
08.2017 - 07.2019
B Pharmacy -
Savitribai Phule University Pune
06.2014 - 06.2017
H.S.C -
Jawahar Madhyamic Vidyalaya,
04.2011 - 02.2012
S.S.S -
Jawahar Madhyamic Vidyalaya,
02.2009 - 03.2010
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