Sai Sindhu P, M. Pharmacy (Pharmacology)
Date of Birth : 15.08.1986
E-mail : sindhumpharm AT gmail.com
Profile :
Clinical Professional with over all 7 years of experience, including 5 years of relevant work experience in clinical safety or pharmacovigilance.
Professional Experience :
OCT-2015 to Present : Operations scientist, Quintiles, Bangalore, India.
OCT-2014 to SEP-2015 : Senior Drug Safety Associate, Quintiles, Bangalore, India.
OCT-2012 to SEP-2014 : Drug Safety Associate, Quintiles, Bangalore, India.
MAY-2010 to APR-2012 : Assistant professor in clinical pharmacology, Andhra Pradesh, India
Professional Skills :
** 5 years experience in triage, case processing, narrative writing and reporting of Individual Case Safety Reports (ICSRs) of Clinical trials and post-marketing Studies.
** Coding of adverse reactions with the help of MedDRA.
** Having knowledge on generate follow up queries and sending Follow-up requests
** Experience in performing ICSR reconciliations with business partners
** Knowledgein reviewing literature screening search results, identifying ICSRs.
** assesses case severity in order to prioritize follow-up
** Profound knowledge on SCEPTRE data base and having Basic knowledge on ARGUS
** Having excellent skills on MS Word and excel.l
Education :
M. Pharmacy (Masters in Pharmacy) : 2008-2010; with 75% result.
B. Pharmacy (Bachelor of Pharmacy) : 2004-2008; with 70% result.
Languages :
English : Fluent
Hindi, Telugu : Fluent
Work Experience Description :
Quintiles(OCT-2012 to present)
Therapeutic Area : Cardiovascular, Anti-Psychotic drugs, Immunology.
Role & Responsibilities :
** Drug safety associate (OCT-2012 to SEP-2014).
** Receive, triage, review and process Pharmacovigilance data from various sources (Solicited, Spontaneous (Legal reports, Literatures, Blogs) on time and with quality standards.
** Perform data entry for tracking and Pharmacovigilance databases, coding relevant medical terminology by using MedDRA, writing descript narratives, generating queries pertinent to the case, performing quality review, coordinating translations and ensuring reports are sent to the customers within assigned deadlines.
** Assess Pharmacovigilance data reportable to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight.
** Handling of operations mails on daily basis, performing consistency checks of labeling, PT checks, Reporter checks and Approval number checks. Reviewing Targeted Follow-up Questionnaires (TFUQs) inconsistency checks on daily basis.
Role & Responsibilities :
** Senior Drug safety associate (OCT-2014 to SEP-2015)
** Triage, process and performing quality review of the reports received under tighter time lines with high quality.
** Work closely with the Project lead on data analysis, monitor and manage the ICSR workflow.
**
Train the new associates from end to end Workflow and had given training for 20 new associates
** Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
** Tracking and reconciling of the reports processed, Follow-up requests for reported adverse reactions.
** Work management, work allocation in normal working hours and advance preparation for the DATALOCK completion.
Role & Responsibilities :
** Operations scientist/ Back-up lead, ICSRs (OCT-2015 to Present)
** Work closely with the Project lead on data analysis, monitor and manage the ICSR workflow.
** Train the new associates from end to end Workflow.
** Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
** Attending client calls and meetings.
** Conducting meetings and sessions regarding the new updates and same in cascading to the team.
** Handling of adverse event product quality complaint issues, reviewing daily and monthly PQC reports.
** Reviewing of deviation memos in the team and submitting same to the compliance team.
** Handling of CAPA related activities across the floor for validity of the case and company causality.
** Assist management with departmental resource planning and work scheduling for current and completed projects to make sure deliverables are met
** Implement and support operational decisions as determined and instructed by senior management.
** Prioritization and organization of daily workload with the team to maintain regulatory compliance and quality standards.
** Review of Managers daily reports to ensure compliance monitoring of edit check reports.
** Review aggregate reporting calendar and ensure all cases required for aggregate reporting are processed within the required timeline.
** Participation in inspection and audit interviews
** Assistance in preparing responses for Corrective Action Plan issues as required
Siddhartha Institute of Pharmacy (MAY-2010 to APR-2012):
Role & Responsibilities :
** Assistant Professor
** Teaching Pharmacology and clinical pharmacology
Publications/ Presentations :
** Oral Presentation on Pharmacovigilance awareness program in Chalapathi institute of Pharmacy, Guntur, India in APR-2017
** Participated and Presented paper on “Evaluation of Nelumbo nucifera for anti-diabetic activity” in the NATIONAL CONFERENCE at Samuel George college of Pharmacy, Markapur, India
** Participated and Presented poster on “Evaluation of Bauhinia tomentosa for anti-cancer activity” in the INTERNATIONAL CONFERENCE ON UPDATES ON PROTEIN DRUG DISCOVERY, FORMULATION AND PRODUCTION CHALLENGES held during 28th and 29th October 2011 at Sri Padmavathi University, Tirupathi, India.
** Participated and Presented paper on “Role of Biomarkers in Pharmacy” in the NATIONAL CONFERENCE at Vignan Mahotsav-2012, Andhra Pradesh, India.
** Research article on Evaluation of Nelumbo nucifera for anti-diabetic activity in Indian journal pharmaceutical education and research.
Achievements :
** Subject matter expert (SME) at the center level
** Received 20 times Work worth Doing (WWD) Reward-Applause awards in 5 years for achieving highest quality, productivity and contribution towards team work.
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