Kavirat Srinivasa Sri Harsha
Patient Safety
Guntur
Summary
A patient safety professional with 10+ years of experience in developmental and post marketing stage. Experienced in directing activities of workgroups. Develops strategies, provides training, sets goals and obtains team feedback. Excellent interpersonal and communication skills.
Currently working in a team of 50+ associates with immaculate planning, and organizational skills. Handling operations team, audits, and inspections. Experienced in handling patient safety aspects in clinical trial which includes internal coordination with data management, regulatory, clinical colleagues and external coordination with investigators, CRA's and vendors. Good understanding of signal detection and Aggregate reports.
Overview
11
11
years of professional experience
7
7
years of post-secondary education
Work History
Team Leader
Cognizant Technology Solutions
Gurugram
9 2021 - Current
- Handling team of 15 who are working on literature surveillance and handle (Triage, Data Entry, Quality review, medical review, and Case submission for solicited and unsolicited reports) in accordance with organization policies and applicable regulations
- Discussing all operational parameters including monthly volume trends, SLA metrics, Quality Analysis, Reconciliation status, compliance metrics during joint operational monthly review with client
- Addressing weekly quality connects with client
- Apprising performance and guiding professional development Providing guidance and review of offerings-related activities, including scope of work, objectives, timelines and quality of deliverables. Track attendance on daily basis and maintaining acceptable adherence rate. Providing feedback to team on key performance indicators including quality and productivity. Actively involved in project billing metric preparation.
- Cross-trained existing employees to maximize team agility and performance
- Accomplished multiple tasks within established timeframes
- Onboarded new employees with training and new hire documentation
- Maintained professional, organized, and safe environment for employees.
- Developed and maintained relationships with customers and vendors through account development
- Monitored and analyzed business performance to identify areas of improvement and make necessary adjustments
- Managed and motivated employees to be productive and engaged in work
- Communicated clearly with employees, and stakeholders to keep everyone on same page and working toward established business goals
- Workflow management which included allocation of cases for data entry, quality review and medical review on daily basis Coached team members in techniques necessary to complete job tasks
- Tracking of cases for completion based on regulatory, SLA and internal timelines Managed and ensured compliant safety reporting in accordance with international reporting regulations and/or standard operating procedures.
- Responsible for providing mid-year and annual ratings. Conducting Process improvement programs for under performing associates.
- Tracking of client mail boxes for queries and allocating it to designated associates as well as ensuring their completion within timelines.
- Set performance expectations for team, monitoring progress towards goals and providing constructive feedback as needed.
- Participated in audit/inspection as required Initiated process improvement Plan in term of quality to improve project Conducted interviews for project
- Worked different stations to provide optimal coverage and meet production goals
- Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills
- Trained new team members by relaying information on company procedures and safety requirements.
SENIOR DRUG SAFETY ASSOCIATE
Bioclinica
Mysuru
09.2017 - 09.2021
- Complete Handling of Global Safety Mail box and Triage activity of all type of ICSRs and product quality complaints (PQC)
- Acknowledging partners and internal/external stake holders on timely manner
- Handling of product quality complaints (PQC) and recording Track wise numbers of internal references
- Doing Pre-Triage activity
- Segregation of emails in order to prioritize them as fast track reports
- Triage and Book in of incoming cases to prioritize for daily workflow management
- Reaching to partners, vendors and investigating sites to get source document as per agreements
- Raising queries to partners, vendors and investigating sites for clear documents in case of discrepancy or it is illegible
- Placing order for Translation in case of Foreign text noticed in document
- Setting dead line for delivery
- Notifying priority cases to leads in order to meet time Internal and partner timelines
- Enter and track priority and live follow-up cases in Fast track tracker
- Keenly track cases until cases are submitted and open new version to meet to time lines
- Importing of R2 and R3 cases is daily activity
- Experience on case data entry (including narrative or auto-narrative), manual coding, label
- Creating/generating AE/Product Complaint forms in Product Complaint System
- Handling of Clinical trial reports and reaching to investigator for additional clarifications
- Performing Follow-up activities
- Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
SENIOR DRUG SAFETY ASSOCIATE
Tech Mahindra
Hyderabad
01.2014 - 09.2017
- Triaging case by performing duplicate search for cases in safety database, creating case, prioritizing case according to seriousness criteria
- Ensure all cases enter in tracking tool for tracking
- Managing serious and non-serious adverse reports by accurate and consistent data entry in requirements
- Use of medical dictionaries (WHODD and MedDRA) and business guidance to code medical history, drugs and adverse event terms
- Writing narratives to ensure concise and complete description of adverse reports as per regulatory standards
- Ensuring collection of follow up information and queries resolved
- Assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to clients within assigned deadlines
- Source data verification (Quality Control) ensuring consistency and quality of reports
- Assists in training of other Safety Processing Experts (mentoring) as necessary as well as specific SOP trainings
- Accountable for assessing seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents adhering to SOPs/other controlled documents and regulatory requirements
- Back up team lead activities Case distribution - Involved in case distribution and work allocation to team in accordance with resource availability based on volume and regulatory timelines of cases
- Providing feedbacks and process improvement measures to team for mitigation of slippage of errors at various levels of process
- Engaged in resolving discrepancies and queries in timely manner
- Assisting operations team in generation and implementation of new process improvement measures for project
- Monitoring and reviewing quality metrics of team and involved in disseminating corrective and preventive actions by conducting refresher trainings and update sessions regularly
- Monitoring DLP (Data lack point) cases and complete them within time lines
- Training and mentoring new hires Engaged in conducting periodic training sessions and mentoring new hires with case processing guidelines
- Maintain Training records up to date for each associates
- Providing feedbacks to peers regarding errors and other quality improvement measures in one to one basis to reach precision and accuracy in quality of processed reports.
Education
Masters in Pharmaceutical Science -
Greenwich University, UK
Kent 01.2010 - 04.2011
Graduate Diploma in Management Studies -
United College, UK
London 01.2009 - 04.2010
Bachelors in Pharmacy -
Annamalai University, India
Chidambaram 01.2004 - 07.2008
Skills
Database: Oracle Argus, Arisg Safety Database
Office Tools: MS Word, Excel, Power Point
Team Supervision
Teamwork and Collaboration
Work Planning
Strong Communication Skills
Fullname
Srinivasa Sri Harsha Kavirat
Personal Information
- Date of Birth: 08/15/87
- Nationality: Indian
- Marital Status: Married
Disclaimer
I do hereby declare that the particulars of information and facts stated herein above are true, correct and complete to the best of my knowledge and belief.
Timeline
SENIOR DRUG SAFETY ASSOCIATE
Bioclinica
09.2017 - 09.2021
SENIOR DRUG SAFETY ASSOCIATE
Tech Mahindra
01.2014 - 09.2017
Masters in Pharmaceutical Science -
Greenwich University, UK
01.2010 - 04.2011
Graduate Diploma in Management Studies -
United College, UK
01.2009 - 04.2010
Bachelors in Pharmacy -
Annamalai University, India
01.2004 - 07.2008
Team Leader
Cognizant Technology Solutions
9 2021 - Current
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