Dr. Umarani Rameswaran

Experience

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  ICON plc

  Jan 2008 - Nov 2009

  Drug safety Associate

  Performed data entry of adverse drug events into a safety database ensuring that the cases are complete and consistent within the time frame.Independently writen clear concise case narratives for serious and non-serious cases.Experience in handling Argus, ARIS-g, Empirica Trace safety database.Performed case processing adverse events from Clinical Trials, Post-marketing studies and Literature studies.Identifying areas of concern within the team and raising the issues with the team lead. Show less

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  UnitedHealth Group

  Nov 2009 - Apr 2010

  Sr Pharmacovigilance coordinator

  Case processing project lead for oncology trials.Back-up pharmacovigilance manager managing a team of 15 associates.Assist in the safety management activities for phase 3 clinical trial.Responsible for tracking internal audits and implementing best practice.Excellent working knowledge of MedDRA and WHO DRUG coding dictionaries.Performed periodic reconciliation of SAEs between the safety database and clinical trial database for ongoing clinical trials.

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  ICON plc

  Jun 2010 - now

  Serve as the project director for multiple studies and ensured project safety activites are completed in accordance with company standards.Coordinating with other departments such as regulatory affairs, medical writing, data management, systems team for smooth project deliverables.Attending regular project governance call with the sponsor presenting project quality metircs, addressing queries from sponsor and showcasing the achievements.Reporting directly to VP and part of VPs leadership team Leadership role for PVG & Safety linked global team.Responsible for line management of Pharmacovigilance and Safety Management team providing guidance and support.Responsible for key sales support for Pharmacovigilance and Safety team by providing inputs into Request For Proposals (RFPs), pricing and bid defence meeting support.Stays up to date with Pharmacovigilance (PV) industry changes that may impact global PV operations. Subject Matter Expert (SME) to interprets PV guidance as related to systems and makes plans to adapt company systems and processes as appropriate Regulatory and PV & Safety functions. Show less Managed multiple projects and ensured the projects run accurately and in accordance with company standards, regulatory requirements, and contractual obligations to sponsors.As a manager, created a culture of process improvement with a focus on streamlining processes adding value to the business and meeting client needs.Streamlined department expertise by establishing focus groups within as: ICSR management, Aggregate reports, Safety Database Administration, Reconciliation and Project Management.Ensured all project safety activities are completed in accordance with Company Standard Operating procedure, Study Specific Procedures, regulatory requirements, and Sponsors processes.Always kept leadership team appraised of potential/actual staffing issues and develop solutions by creating openings, utilized shared support from other teams.Maintained quality review metrics and attended monthly project quality meetings.Assisted with maintaining of project budgets and oversight by identifying out of scope activities which improved the business.Assisted leadership team with resourcing and business development activities by attending bid defence meetings with several sponsors.Managed a team of 15 associates with their line management and conducted recreation, leisure activity which ensured improvement iin employee retention. Show less Served as a project lead to case processing and safety reporting projects and managed in all aspects of departmental activities.Safety Regulatory Lead/SME supporting safety regulatory expedited and periodic submissions to CA, EC/IRB and Investigators.Maintained ICSR and aggregate report regulatory submission compliance across all PV projects throughout the tenure.Ensured the daily project safety activities are completed in accordance with the company standards.Authored several WP/SOPs for Pharmacovigilance/Safety Regulatory Reporting processes.Subject Matter expert (SME) in country specific regulations which ensured timely submissions as per the regulations.Manintained inspection readiness by managing the day to day activities and executed oversight responsibilites as defined in the applicable standard operating procedure and work instructions. Show less

  • Project Director/Senior Manager Pharmacovigilance

    Jan 2023 - now

  • Project Manager/Drug Safety Manager Pharmacovigilance

    Jun 2018 - Dec 2022

  • Drug Safety Coordinator

    Apr 2015 - Jun 2018

  • Sr Drug Safety Associate

    Jun 2010 - Mar 2015
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  Tooth Time Dental Studio

  Sept 2012 - now

  Proprietor & Chief Consultant

  Evaluate patient oral health conditions and design a comprehensive treatment plan that fit patient's individual need.Establish and maintain periodontal health by performing periodontal procedures: prophylaxis; scaling; root planning and periodontal maintenance.Perform restorative proceudres to remove caries and restore the loss of function and aesthetics.Rehablitate the loss of masticatory function through the fabrication of fixed and removable prosthesis such as crowns, bridges, implants, RPD and complete denture.Perform root canal treatments.Perform surgical and non-surgical extractions.Management of medically compromised patients.Dental laser specialist, Cosmetic/Aesthetic dentist: composite restorations; Direct and indirect vaneers; Aligners. Show less