Tejasree Chelluboina
Pharmacovigilance Manager
Hyderabad
Summary
Service-oriented Pharmacovigilance Manager with commitment to excellence and more than 10 years of experience. Strong background in Pharmacovigilance and Clinical research who is passionate about the safety in drug development / post-marketing use and seeking a challenging and rewarding career.
Overview
11
11
years of professional experience
6
6
years of post-secondary education
Work History
Manager, Pharmacovigilance
PPD, Part of Thermo Fisher Scientific
08.2024 - Current
- Manage multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
- Manage budgets effectively, ensuring optimal financial performance while investing in necessary resources for business growth.
- Actively involved in reviewing the financial oversight forms and Contract Modification trackers and Project data reviews (PDRs) along with audit readiness oversight.
- Regularly monitor the study start-up, maintenance, and termination activities of the project
- Achieved departmental goals by developing and executing strategic plans and performance metrics.
- Maintains good communications with other functional groups and collaborates with other employees in problem solving and systems improvement.
- Built high-performing teams through effective recruitment, onboarding, and talent development initiatives.
- Reviews regulatory and pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- Provides plans and accurate forecasts for all projects. Prepares and presents proposals.
- Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.
- Approves courses of action on salary administration, hiring, corrective action, and terminations.
- Reviews and approves time records, expense reports, requests for leave, and overtime.
Associate Manager, Pharmacovigilance
PPD, part of Thermo Fisher Scientific
12.2021 - 07.2024
- Proactively assess resourcing within the project team and regularly monitor utilization and productivity targets of staff relative to the handle times or other variables defined in the budget.
- Ensure that the team meets regulatory and contracted timelines as defined in the project's study management plan (SMP).
- Ensure each team member has the appropriate training and knowledge to perform daily responsibilities to fulfil contractual obligations.
- Reduce unsupported hours via a process improvement.
- Review the project performance and work together with the team to identify areas of process optimization to evaluate the current process as well as implementation (as applicable).
- Ensure succession planning is in place by identifying leads and/or potential leads for the project and ensuring they have the appropriate learning or exposure to fulfil their roles.
- Appropriate utilization of financial, compliance and performance monitoring tools
- Routine review of performance with direct reports. Involved in the performance review and appraisals of the direct reports.
- Support the PV standards team in the continued development of procedures, processes, and PV standards.
- Improve PV training compliance for team by ensuring that each team member is up to date with their assigned courses
- Train/Mentor staff to provide negotiating skills and overall understanding of the client perspective
Principal Safety Specialist
PPD, part of Thermo Fisher Scientific
04.2021 - 12.2021
- Perform management tasks as appropriate.
- Supervision over Pharmacovigilance team where majority of time is utilized ensuring project work is delivered on time.
- Perform project management for multiple projects.
- Serve as mentor to PVG staff for Serious Adverse Event (SAE) processing, SAE database, regulatory reporting, narrative generation and quality control activities.
- Provide department training for pharmacovigilance procedures/processes.
- Assist in preparation and revision of department SOPs.
- Prepare for and attend audits.
- Work with Project Teams, Client Company and Investigators regarding SAE activities as needed.
- Review compliance of expedited safety reporting on assigned projects and escalates problems or issues to PVG manager.
- Provide project specific safety training to PPD Clinical on assigned projects.
- Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into adverse event database, review of entered cases for quality, consistency and accuracy, follow-up with reporter and /or associated HCP, tracking of reports, and reporting activities.
- Code adverse event terms and write narratives according to client convention.
- Review literature articles/abstracts and process adverse event reports from literature per program and regulatory guidelines.
- Resolve complex problems through in-depth evaluation of various factors.
- Effectively communicate with managers, team members, client contacts and adverse event reporters, and often serve as program lead to disseminate information to team members. Assist program management team with day-to-day operational needs.
Senior Safety Specialist
PPD
04.2019 - 03.2021
- Reviewed pharmacovigilance publications and information sources to evaluate them for identification of valid ICSRs.
- Reviewed cases entered in the safety database for quality, consistency, and accuracy.
- Mentored and monitored the performance of data entry personnel for improvement of quality and productivity.
- Managed case assignment to the team whenever necessary.
- Trained the new associates regarding Embase literature surveillance activity.
Safety Expert
Vigi Medsafe Private Limited, a division of PPD
04.2018 - 04.2019
- Quality reviewed the literature articles from Embase screened by initial reviewers.
- Identified of valid ICSRs. cluster cases and sending allocation mails to the book-in team
- Quality reviewed of the cases processed by the data entry team in the safety database and forward it to medical review.
Safety Process Associate
Vigi Medsafe Private Limited, a division of PPD
10.2015 - 03.2018
- Involved in the case processing activities including duplicate check and book-in, data entry and quality review of cases processed in the safety database.
- Involved in the author follow-up attempts with appropriate questionnaire for the missing information.
Associate Research Analyst
Thomson Reuters International Services Private Limited
11.2014 - 10.2015
- Worked in the Clinical Trial Intelligence (CTI) department with the job role involving trial intake, trial processing, data retrieval, analysis and report writing.
Education
Master of Science - M.S (Pharm.) Biotechnology
National Institute of Pharmaceutical Education And Research
NIPER, Mohali 07.2012 - 06.2014
Bachelor of Science - B. Pharmacy
Priyadarshini College of Pharmaceutical Sciences
Hyderabad 06.2008 - 05.2012
Skills
Operations management
Business development
Financial management
Performance management
Timeline
Manager, Pharmacovigilance
PPD, Part of Thermo Fisher Scientific
08.2024 - Current
Associate Manager, Pharmacovigilance
PPD, part of Thermo Fisher Scientific
12.2021 - 07.2024
Principal Safety Specialist
PPD, part of Thermo Fisher Scientific
04.2021 - 12.2021
Senior Safety Specialist
PPD
04.2019 - 03.2021
Safety Expert
Vigi Medsafe Private Limited, a division of PPD
04.2018 - 04.2019
Safety Process Associate
Vigi Medsafe Private Limited, a division of PPD
10.2015 - 03.2018
Associate Research Analyst
Thomson Reuters International Services Private Limited
11.2014 - 10.2015
Master of Science - M.S (Pharm.) Biotechnology
National Institute of Pharmaceutical Education And Research
07.2012 - 06.2014
Bachelor of Science - B. Pharmacy
Priyadarshini College of Pharmaceutical Sciences
06.2008 - 05.2012
Similar Profiles
Shivani Shivani null
Senior Regulatory Affairs Specialist at PPD, part of Thermo Fisher ScientificSenior Regulatory Affairs Specialist at PPD, part of Thermo Fisher Scientific
Strahil PanekovStrahil Panekov
Senior Finance Analyst at PPD, Part of Thermo Fisher ScientificSenior Finance Analyst at PPD, Part of Thermo Fisher Scientific
Skylar ReedSkylar Reed
Sr. Automation Specialist, Service at PPD, Part of Thermo Fisher ScientificSr. Automation Specialist, Service at PPD, Part of Thermo Fisher Scientific
PASULA GANESHPASULA GANESH
System Admin at TEK GALAXY SOLUTIONSSystem Admin at TEK GALAXY SOLUTIONS
Bhavya ReddivariBhavya Reddivari
SAP GRC Consultant at IBMSAP GRC Consultant at IBM