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Showi Babu_Resume

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Showri Chowdary
Showri Chowdary

This curriculum vitae outlines the experience and qualifications of Showri Babu Chava. He has over 2 years of experience in core pharmacovigilance at Mylan Laboratories Limited in Bangalore, India. His roles include case triage, processing, quality review, regulatory reporting and training. He has a Master's degree in Pharmacy and is proficient in pharmacovigilance software and Microsoft Office applications.

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Curriculum Vitae Page 1 SHOWRI BABU CHAVA D No: 4-203, K.M Agraharam, Mulakalur (post),Narasaraopet, Guntur –522601 : Showri.pharma@gmail.com : + 91 8008331347 C A R E E R O B J E C T I V E S Seeking a challenging environment in Pharmacovigilance that encourages continuous learning which provides exposure to new ideas, stimulate personal and professional growth on the platform of Pharmacovigilance. SUMMARY A creative support professional with a record of increased responsibility. Proficient in prioritizing and completing tasks in a timely manner with flexible to multitask when necessary. Diverse experience in case processing and quality review both of serious and non-serious cases from various sources. EXPERIENCE: 2.4 Years of Core Pharmacovigilance Experience Present: Working as Senior Associate in Global Pharmacovigilance Department at Mylan Laboratories limited, Bangalore. (19-Feb-2014 to till date) JOB PROFILE: Triage:  Initial check for the validity of the Individual Case Safety Reports (ICSRs) and search database to prevent duplicate entries.  Relevant case triage by case creation and case identification through importing process in ARGUS with exported XML file from EMA site.  Handling of XML cases and E2B import cases.  Triage of cases to determine seriousness and reporting requirements for prioritization of daily workflow to meet internal and regulatory timelines.  Quality review of the validation and triage of the Individual Case Safety Reports (ICSRs) according to the process requirements.  Updating and maintaining trackers along with Quality review of the various critical trackers related to triage as applicable as per the department.
Curriculum Vitae Page 2  Monitoring the regular cases inflow and reporting it to the immediate manager to meet requirements for prioritization of daily workflow.  Performing monthly reconciliation of ICSR reports from APAC and EU region licensing partners and distributors as per the safety data exchange agreement with the partner obligations (SDEA).  Provide oversight and team mentoring on Triage aspects to the newer staff member. Case processing:  Case processing of serious and non-serious cases including drug coding through WHO-DD, coding of adverse reaction, medical conditions, lab data through MedDRA dictionary and listedness/labeling.  Has been trained on MedDRA coding of the adverse events, serious adverse events, and of medical history findings.  Processing of cases that include case reports from various sources including Literature source (RPS), Spontaneous cases, Clinical Trial cases, Regulatory authority.  Perform peer level QC which helps to increase the quality of processed safety data.  Responsible for developing concise, accurate and well-written case narratives and checking the completeness and accuracy of the data entered in the various fields.  Publishing quality sheets for the data entry persons for the cases processed.  Providing technical training and monitoring the new hires on case processing and other aspects. Additional activities:  Submissions of serious and non-serious cases based on regulatory requirements.  Scheduling and reporting ICSRs to EU Regulatory Authorities based on the regulatory requirements.  Quality Check of ICSRs processed and submitting through Eudravigilance (Global submission)  Experience in RPS literature cases (PRT Springer Healthcare literature cases)and EMAMLM process
Curriculum Vitae Page 3  Checking E2B gateway on daily basis and retrieving case from Italian Regulatory Authorities, AEMPS Authorities and PRT Springer and assignment of cases for validation.  Expertised on Spanish cases processing, Scheduling and reporting ICSRs to AEMPS.  Expertised on writing WHO Causality for each case.  Expertised on writing French Immutability Assessment (Causality) for each case  Expertised on US-Canada labeling (USPI and PM).  Ensuring compliance with the procedures for supporting activities such as requesting deletions, addition of new code list terms, preparing deviation memos and CAPA etc.  Assess the need for follow up information and issue or draft follow up requests, as applicable  Participate in training programs, meetings, and conferences to continuously improve the process and provide feedback to manager on any challenges/issues or successes.  Participate in conferences related to awareness of company procedures and guidelines to maintain regulatory compliance.  Perform other job duties as assigned by immediate manager.  Good at USFDA submissions through E2B submissions (AERS version 4.6.2) TECHNICAL EXPERTISE:  Expertise in oracle based software like AERS version 4.6.2 and ARGUS Safety 6.0.  Well versed with Microsoft windows XP, windows 7 and Vista, MS Word, MS Excel, MS power point, MS Access (2000, 2003 and 2007 versions) AUDIT EXPOSURE: Actively participated in MHRA, USFDA and Third Party Audits EDUCATION  Masterof Pharmacy from Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Acharya Nagarjuna University, AP, India with 88% in 2013.  Qualified GPAT-2011 (Rank: 1948), NIPER-2011 (Rank: 687)  Bachelor of Pharmacy from Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Acharya Nagarjuna University, AP, India with 87% in 2011  Intermediate from Board of Intermediate, AP, India with 95% in 2006
Curriculum Vitae Page 4  Indian Council for Secondary Education [ICSE], from Loyola Public School, AP, India with 82% in year 2004. PROJECTS  M. Pharmacy: Formulation and Evaluation of Verapamil Hydrochloride Osmotic controlled Drug delivery Matrix tablets:  B. Pharmacy: Formulation and Evaluation of Zolmitriptan Fast Dissolving Buccal Films: PUBLICATIONS:  Published an article in International Journal Of Pharmaceutical Science And Research (IJPSR), on Solubility And Dissolution Rate Enhancement of Olmesartan Medoxomil By Complexation And Development Of Mouth Dissolving Tablets (Acceptance no: IJPSR/RA-2552/04-13) R.L.C.Sasidhar*, S.Vidyadhara, G.V.Maheswari, Ch.Showri Babu and E.Wilwin  Published an article in Scholars research Library, on Formulation And Evaluation Of Zolmitriptan Fast Dissolving Buccal Films.2013,5(4) 145-152S.Vidyadhara, , T.Bala Krishna ,Ch.Showri Babu and D.Lakshmi Harika PERSONAL SKILLS:  Positive Attitude, Determined, High Energies.  Hard Working, Organized, Sincere and well-structured at work.  Good decision making and analytical skills.  Able to work effectively as part of team.  Organized Emphasis on timeliness and quality.  Willingness to learn and handle responsibilities. SEMINARS & PRESENTATIONS  Presented an E-poster at National APTICON -2013 on Formulation and Evaluation Of Verapamil Hydrochloride Osmotic Controlled Matrix Tablets (Association of Pharmaceutical Teachers Of India) and received 2nd place.  Participated in Elocution and Quiz in National Work Shop on Waste Management In Chemical and Allied Industries at R.V.R & J.C College ofEngineering, Guntur and won 2nd place.
Curriculum Vitae Page 5  Presented a paper (oral) in the National seminar on Formulation and Evaluation Of Losartan Potassium Osmotic Controlled Matrix Tablets at Vignan Pharmacy Collage, Guntur and won 3rd place.  Presented a paper in the International seminar on Emerging Trends In Implantable Therapeutics at Acharya Nagarjuna University, Guntur.  Presented a paper in the 62nd Indian Pharmaceutical Congress 2010 on Recent Advances in Transdermal Target Drug Delivery Systems held at Manipal University, Manipal.  Participated in the 4th IPA Student Congress held at St.Peters College of Pharmacy,Warangal. PERSONAL DETAILS Father’s Name : Ankammarao Chava Languages Known : English, Telugu and Hindi Date of Birth : 18th September, 1988 Sex : Male Nationality : Indian Marital Status : Single Corresponding Address : Showri babu.Chava S/O Ankammarao D No: 4-203, K.M Agraharam, Mulakalur (post), Narasaraopet, Guntur –522601 I hereby declare that all the information provided above is correct to the best of my belief and knowledge. Showri Babu Chava Bangalore

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Showi Babu_Resume

  • 1. Curriculum Vitae Page 1 SHOWRI BABU CHAVA D No: 4-203, K.M Agraharam, Mulakalur (post),Narasaraopet, Guntur –522601 : Showri.pharma@gmail.com : + 91 8008331347 C A R E E R O B J E C T I V E S Seeking a challenging environment in Pharmacovigilance that encourages continuous learning which provides exposure to new ideas, stimulate personal and professional growth on the platform of Pharmacovigilance. SUMMARY A creative support professional with a record of increased responsibility. Proficient in prioritizing and completing tasks in a timely manner with flexible to multitask when necessary. Diverse experience in case processing and quality review both of serious and non-serious cases from various sources. EXPERIENCE: 2.4 Years of Core Pharmacovigilance Experience Present: Working as Senior Associate in Global Pharmacovigilance Department at Mylan Laboratories limited, Bangalore. (19-Feb-2014 to till date) JOB PROFILE: Triage:  Initial check for the validity of the Individual Case Safety Reports (ICSRs) and search database to prevent duplicate entries.  Relevant case triage by case creation and case identification through importing process in ARGUS with exported XML file from EMA site.  Handling of XML cases and E2B import cases.  Triage of cases to determine seriousness and reporting requirements for prioritization of daily workflow to meet internal and regulatory timelines.  Quality review of the validation and triage of the Individual Case Safety Reports (ICSRs) according to the process requirements.  Updating and maintaining trackers along with Quality review of the various critical trackers related to triage as applicable as per the department.
  • 2. Curriculum Vitae Page 2  Monitoring the regular cases inflow and reporting it to the immediate manager to meet requirements for prioritization of daily workflow.  Performing monthly reconciliation of ICSR reports from APAC and EU region licensing partners and distributors as per the safety data exchange agreement with the partner obligations (SDEA).  Provide oversight and team mentoring on Triage aspects to the newer staff member. Case processing:  Case processing of serious and non-serious cases including drug coding through WHO-DD, coding of adverse reaction, medical conditions, lab data through MedDRA dictionary and listedness/labeling.  Has been trained on MedDRA coding of the adverse events, serious adverse events, and of medical history findings.  Processing of cases that include case reports from various sources including Literature source (RPS), Spontaneous cases, Clinical Trial cases, Regulatory authority.  Perform peer level QC which helps to increase the quality of processed safety data.  Responsible for developing concise, accurate and well-written case narratives and checking the completeness and accuracy of the data entered in the various fields.  Publishing quality sheets for the data entry persons for the cases processed.  Providing technical training and monitoring the new hires on case processing and other aspects. Additional activities:  Submissions of serious and non-serious cases based on regulatory requirements.  Scheduling and reporting ICSRs to EU Regulatory Authorities based on the regulatory requirements.  Quality Check of ICSRs processed and submitting through Eudravigilance (Global submission)  Experience in RPS literature cases (PRT Springer Healthcare literature cases)and EMAMLM process
  • 3. Curriculum Vitae Page 3  Checking E2B gateway on daily basis and retrieving case from Italian Regulatory Authorities, AEMPS Authorities and PRT Springer and assignment of cases for validation.  Expertised on Spanish cases processing, Scheduling and reporting ICSRs to AEMPS.  Expertised on writing WHO Causality for each case.  Expertised on writing French Immutability Assessment (Causality) for each case  Expertised on US-Canada labeling (USPI and PM).  Ensuring compliance with the procedures for supporting activities such as requesting deletions, addition of new code list terms, preparing deviation memos and CAPA etc.  Assess the need for follow up information and issue or draft follow up requests, as applicable  Participate in training programs, meetings, and conferences to continuously improve the process and provide feedback to manager on any challenges/issues or successes.  Participate in conferences related to awareness of company procedures and guidelines to maintain regulatory compliance.  Perform other job duties as assigned by immediate manager.  Good at USFDA submissions through E2B submissions (AERS version 4.6.2) TECHNICAL EXPERTISE:  Expertise in oracle based software like AERS version 4.6.2 and ARGUS Safety 6.0.  Well versed with Microsoft windows XP, windows 7 and Vista, MS Word, MS Excel, MS power point, MS Access (2000, 2003 and 2007 versions) AUDIT EXPOSURE: Actively participated in MHRA, USFDA and Third Party Audits EDUCATION  Masterof Pharmacy from Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Acharya Nagarjuna University, AP, India with 88% in 2013.  Qualified GPAT-2011 (Rank: 1948), NIPER-2011 (Rank: 687)  Bachelor of Pharmacy from Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Acharya Nagarjuna University, AP, India with 87% in 2011  Intermediate from Board of Intermediate, AP, India with 95% in 2006
  • 4. Curriculum Vitae Page 4  Indian Council for Secondary Education [ICSE], from Loyola Public School, AP, India with 82% in year 2004. PROJECTS  M. Pharmacy: Formulation and Evaluation of Verapamil Hydrochloride Osmotic controlled Drug delivery Matrix tablets:  B. Pharmacy: Formulation and Evaluation of Zolmitriptan Fast Dissolving Buccal Films: PUBLICATIONS:  Published an article in International Journal Of Pharmaceutical Science And Research (IJPSR), on Solubility And Dissolution Rate Enhancement of Olmesartan Medoxomil By Complexation And Development Of Mouth Dissolving Tablets (Acceptance no: IJPSR/RA-2552/04-13) R.L.C.Sasidhar*, S.Vidyadhara, G.V.Maheswari, Ch.Showri Babu and E.Wilwin  Published an article in Scholars research Library, on Formulation And Evaluation Of Zolmitriptan Fast Dissolving Buccal Films.2013,5(4) 145-152S.Vidyadhara, , T.Bala Krishna ,Ch.Showri Babu and D.Lakshmi Harika PERSONAL SKILLS:  Positive Attitude, Determined, High Energies.  Hard Working, Organized, Sincere and well-structured at work.  Good decision making and analytical skills.  Able to work effectively as part of team.  Organized Emphasis on timeliness and quality.  Willingness to learn and handle responsibilities. SEMINARS & PRESENTATIONS  Presented an E-poster at National APTICON -2013 on Formulation and Evaluation Of Verapamil Hydrochloride Osmotic Controlled Matrix Tablets (Association of Pharmaceutical Teachers Of India) and received 2nd place.  Participated in Elocution and Quiz in National Work Shop on Waste Management In Chemical and Allied Industries at R.V.R & J.C College ofEngineering, Guntur and won 2nd place.
  • 5. Curriculum Vitae Page 5  Presented a paper (oral) in the National seminar on Formulation and Evaluation Of Losartan Potassium Osmotic Controlled Matrix Tablets at Vignan Pharmacy Collage, Guntur and won 3rd place.  Presented a paper in the International seminar on Emerging Trends In Implantable Therapeutics at Acharya Nagarjuna University, Guntur.  Presented a paper in the 62nd Indian Pharmaceutical Congress 2010 on Recent Advances in Transdermal Target Drug Delivery Systems held at Manipal University, Manipal.  Participated in the 4th IPA Student Congress held at St.Peters College of Pharmacy,Warangal. PERSONAL DETAILS Father’s Name : Ankammarao Chava Languages Known : English, Telugu and Hindi Date of Birth : 18th September, 1988 Sex : Male Nationality : Indian Marital Status : Single Corresponding Address : Showri babu.Chava S/O Ankammarao D No: 4-203, K.M Agraharam, Mulakalur (post), Narasaraopet, Guntur –522601 I hereby declare that all the information provided above is correct to the best of my belief and knowledge. Showri Babu Chava Bangalore