Dance
JERATH KIRAN KUMAR THALLAPPALLY
Associate Manager
Bangalore
Summary
Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.
Overview
7
7
years of professional experience
3
3
years of post-secondary education
2
2
Languages
Work History
Associate Manager
IQVIA RDS INDIA PVT LTD
Bangalore
09.2021 - Current
- Coordinated resources from stakeholders and mapped out project deliverables.
- Oversaw training and onboarding process for all newly hired employees within Team.
- Mentored and supported PV department employees to create strong workplace culture.
- Kept records accurate, detailed and fully compliant with reporting requirements to meet state, local and federal housing requirements.
- Mentored team members to enhance professional development and accountability in workplace.
- Strengthened merchandising and promotional strategies to drive customer engagement and boost sales.
- Increased employee performance and job satisfaction to strengthen retention and engagement.
- Strengthened operational efficiency to remain cost-effective while maintaining quality service.
- Developed organizational structure to outline and direct rules, roles and responsibilities.
Operations Specialist 2
IQVIA RDS INDIA PVT LTD
Bangalore
07.2019 - 08.2021
- Back up to manager in all team related activities
- Training or grooming associates in handling activities including QRRT's, Learning sessions, presentations
- Focusing on Process related, Quality and Productivity in team
- Handling daily and weekly due cases in respective to timelines (internal & external)
- Performing Serious and non serious cases quality review
- Conducting Team activities to maintain work time balance
- Attending client meetings and presenting status of required case scenarios.
Operation specialist 1
IQVIA RDS INDIA PVT LTD
Bangalore
03.2017 - 06.2019
- Process ICSRs according to applicable regulations, guidelines, standard operating procedure (SOPs) and project requirements
- Receive, review, process data from various sources on time to meet quality standards
- Perform data entry for tracking, coding relevant medical terminology, writing descript narratives, generating queries pertinent to case, performing quality review, assisting with reconciliation, driving case closure, requesting translations and ensuring ICSR are processed within assigned timelines
- Address emails from stakeholders and customers supporting ICSR activities within timelines and seek clarifications as appropriate local safety officer (LSO), Medical reviewers, customer POCs etc.
- Contribute to achieve individual/team deliverables within safety Operation or service lines as appropriate
- Provide and impart technical and process information to management and members of operational team on project specific issues
- Provide oversight to have good understanding of operations, metrics, productivity and initiatives
- Establish and maintain effective operations communications i.e. attend project meetings, provide regular feedback to operations team manager/team members ok project deliverables
- Out of scope work challenge/issues and successes
- Liaise with Manager in proactively identifying issues and proposing solutions, providing them with technical support, reports, metrics, status
- Ensure compliance to IQVIA high quality standards and work with Managers constructively in matrix framework to achieve project and customer deliverables
- Participate and/or deliver training across lifecycle safety process service offerings, participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies
- Assist operation team with tasks and be back up for identified activities
- Ensure all required training is executed in timely fashion and documented
- Contribute to innovation and process improvements
- Perform other duties as assigned.
Safety Associate 2
Quintiles Research India Pvt Ltd
Bangalore
03.2016 - 02.2017
- Worked as Line manager’s back up for work allocation and managing team activities in times of necessity that includes managing queries and routing/responding to client queries well within timelines
- Track all cases in Workflow to manage departmental workload and to ensure adherence to processing timelines
- Was Part of SME Panel for training/mentoring new hires on complete working of Safety database and conducted various trainings and Guideline/SOP/WI refresher sessions actively in organization
- Worked on Global Safety Database
- Perform Independent Quality Review of Adverse Event Reports (ICSRs) in Global Safety Database SCEPTRE which includes verifying Med DRA coding, Product coding using CPD and WHO DD, verifying safety narratives according to guidelines, Standard Operating Procedures (SOPs) and to check whether process adhering to regulatory protocols
- Ensure that all safety reports received from any source (clinical trials and post-marketing), for assigned products and/or studies, are appropriately triaged, processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures
- Ensure consistency in the initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy and legibility
- Exercise judgment and use knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness and expectedness/listedness including performing consistency checks for labelling, reporter qualification, and preferred terms
- Well versed in triage, registry, case process and quality review of clinical trial safety data and post-marketing safety data received as a SAE and adverse event reports from various sources
- Entering the data into the safety database- SCEPTRE accurately, coding terms, ensuring initial reports and updated follow up reports are submitted to the regulatory agencies within the timelines
- Writing case narratives for spontaneous, literature, clinical trial, serious and non-serious adverse events
- Ensure appropriateness of MedDRA and WHO-DRL coding, inclusive of manual coding
- Liaise with assigned Physicians in Drug Safety to ensure that appropriate medical review and assessment is provided for assigned case reports
- Mentor and train Safety Associate Trainees in the execution of their daily functions and on complete working of the Safety database by identification of training areas, prepare training modules, conduct sessions, carry out assessments and prepare individual development plan.
Safety Associate
Quintiles Research India Pvt Ltd
Bangalore
09.2015 - 02.2016
- Process Lifecycle Safety data according to applicable regulations, guidelines, standard operating procedures (SOPs) and project requirements
- Receive the safety data from the source, prioritize the work as per ICH date, asses the report for a valid case, seriousness, causality, perform duplicate search in the safety database to avoid duplicate reports and finally case creation in safety database (Triage)
- End to end case processing in safety database starting from a data entry, selecting the adverse events, identifying the suspect drug, assessing for expectedness (labelling) by using reference safety information(RSI), assessing de-challenge and re-challenge and writing descript narratives
- Clarification of unclear or illegible information from the Local Safety Officer or Call Centre and customer communication as per the project requirement
- Discuss source documents, coding conventions and ad-hoc queries with Medical assessment Physician
- Coding of adverse events and drugs for consistencies as per regulators by using dictionaries like Med DRA for coding medical terminologies and WHODRL for coding drugs
- File a product complaint where a product complaint is associated with an adverse event
- Perform thorough quality review of a case, check for labelling errors and discrepancies in narrative and set a follow-up letter to consumer as per follow up guidelines and reporting the case to regulatory bodies
- Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities in the team
- Determine if any additional information or clarification is needed and send queries to the originator
- Preparation of deviation memo as necessary
- Request deletions/ Admin edit requests as necessary
- Other Case processing related activities (Eg
- Review of consistency checks, reconciliation etc)
- Determine necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge
- Provide inputs for any process improvement
- Participate in daily quality and workflow update calls for continuous process improvement
- Mentor and train Drug Safety Associate and Drug Safety Coordinators in the execution of their daily functions and on complete working of the Safety database by identification of training areas, prepare training modules, conduct sessions, carry out assessments and prepare individual development plan
- Quality reviewer: certified as a quality reviewer within 6 months of the tenure and assist with Quality Control reviews of others’ cases to ensure the accuracy, integrity and completeness of information entered into the safety database according to Standard Operating Procedures (SOP).
Safety Associate Trainee
Quintiles Research India Pvt Ltd
Bangalore
03.2015 - 08.2015
- Started case processing on serious and Non-serious cases
- Therapeutic Areas Worked - Immunosuppressive drugs
Education
Master of Science - Pharmaceutics
Jayamukhi Institute Of Pharmaceutical Sciences
Warangal 03.2011 - 07.2014
Skills
Excellent interpersonal communication
Organizational and leadership skills
Good at handling modules independently and as team
Proficient in MS Word, MS Excel, MS Outlook and MS PowerPoint presentations
Analytical and problem-solving skills
Project management and planning skills
Risk Management
Strategic planning
Operations management
Employee performance evaluations
Interests
Listening Music
Photography
Timeline
Associate Manager
IQVIA RDS INDIA PVT LTD
09.2021 - Current
Operations Specialist 2
IQVIA RDS INDIA PVT LTD
07.2019 - 08.2021
Operation specialist 1
IQVIA RDS INDIA PVT LTD
03.2017 - 06.2019
Safety Associate 2
Quintiles Research India Pvt Ltd
03.2016 - 02.2017
Safety Associate
Quintiles Research India Pvt Ltd
09.2015 - 02.2016
Safety Associate Trainee
Quintiles Research India Pvt Ltd
03.2015 - 08.2015
Master of Science - Pharmaceutics
Jayamukhi Institute Of Pharmaceutical Sciences
03.2011 - 07.2014