Akshaya Moorthy

Experience

• 

  Vivekanandha College of Engineering for Women

  Jan 2013 - Mar 2014

  Worked on the project titled 'In-vitro Anti-Proliferative Potential of leaves of Costus igneus' _ The thesis is aimed at evaluating the anti-proliferative and apoptotic of methanolic extract of Costus igneus on in-vitro MCF breast cancer cell line, and also evaluating its safety to customary human lymphocytes. Project work on Isolation of bacteriophages against drug resistant E.coli strains.

  • Undergraduate Research Fellow

    Dec 2012 - Mar 2014

  • Project Trainee

    Jan 2013 - Aug 2013
• 

  BioLim Company

  Jun 2015 - Jun 2015

  Summer Research Intern

  Worked on a project titled "Studying the toxicological parameters of Mollugu oppositifolia", the study is aimed at evaluating the best solvent for extracting terpenoid from Mollugo oppositifolia using different extraction process and studying the toxicological parameters to prevent damages while consuming it as a pharmaceutical product.

• 

  BioLim Company

  Jan 2016 - Mar 2016

  Research Intern

  Worked on a project titled "Formulating active herbal gel of anti-inflammatory property for transdermal delivery", the thesis aimed at developing a novel herbal gel with high anti-inflammatory property using curcuma longa , piper nigrum and honey. The combination of these three compounds create a synergic effect that can greatly influence the efficacy and potency of transdermal green gel.

• 

  DR.KAMAKSHI MEMORIAL HOSPITAL PVT. LTD., (Inst. Code - 381) CHENNAI

  May 2016 - Jul 2016

  Clinical Research Coordinator

  》Coordinated three phase III clinical trial studies for oncology at a time; acted as liaison between the physician and sponsor》Recruited 6 to 8 subjects for various studies and administered informed consent.》Coordinated, organized and maintained all study documentation, including source documentation, case report forms, study and regulatory binders and patient binders.》Scheduled study visits and necessary testing, including procuring blood, urine, serum, and intestinal specimens.》Assisted in accurate data collection, ordered all protocol requirements and obtained results; prepared, handled and shipped all required research specimens.》Maintained detailed logs regarding the history of subject participation, employee trainings, device components, temperature log etc.》Effectively met deadlines and consistently exceeded expectation for timely data collection and submission.》Conducted patient visits. Knowledge and utilization of Good Laboratory Practice (GLP), Good Clinical Practice (GCP). 》Knowledge of ICH and local regulatory authority regulations regarding drug research and development.》Prepared and processed all documentation through the Institutional Review Board (IRB), including submissions, continuing reviews, amendments and adverse event reporting.》Prepared for and participated in audits conducted by sponsors. Prepared and conducted Ethic Committee meeting.Business or sector: Clinical research, Oncology trials, Human health, Patient Safety. Show less

• 

  ICON plc

  Oct 2017 - May 2019

  》Regulatory Safety Reporting Group Lead for Clinical Trials and Post Marketing Projects, performs project set up and maintenance within Safety reporting Solution and project specific databases. Subject Matter Expert and Secondary Lead for EudraVigilance related activities.》Performs Expedited Reporting of ICSRs/SUSARs to European Medical Agency (EMA) via EVWEB Portal and to MHRA via MHRA ICSR Submission Portal or eSUSAR; performed quality review and checking cases for discrepancies for any errors, compliance tracking and filing of cases.》Administered the entry and maintenance of product via Article 57, extended EudraVigilance Medical Product Dictionary (xEVMPD).》Performs registration and testing with national competent Authorities, being a Responsible Person/Trusted Deputy ensure the completion of EudraVigilance Registration for Sponsors as per EMA requirements.》Performs client registration within Medicines and Health Regulatory Agency (MHRA) 》Performs downloading of Individual case safety Reports and Medical literature Monitoring searches.》Expertise in clinical trial and post marketing specialties as a Safety reporting group lead. Perform maintenance of project regulatory submission compliance and activities invoicing.》Liaises with Sponsors and attend project team meetings and teleconferences as required.》Ensures the entire project specific, Client specific trainings were added to the development path of EudraVigilance-MHRA Team, as a Subject Matter Expert (SME) works to ensures all the trainings are up to date in the development path.》Performs triage and assessment of reportability of cases including literature cases for post-marketing projects in ARGUS and Arisg safety database. Experienced in few client specific databases with their local requirements. Business or sector: Medical safety, Pharmacovigilance, Safety Reporting, Drug Safety, Regulatory affairs. Show less 》Administered the entry and revision of applicable information into the safety reporting portal for initial or follow-up reports received via email.》Performed Expedited Reporting to Food and Drug Administration (FDA) via Safety Reporting Portal.》Performed quality review and checking cases for discrepancies for any errors.》Attended project team meetings and teleconferences as required.》Performed compliance tracking and filing of cases.》Safety Reporting Group Lead for post-marketing project.Business or sector: Medical safety, Pharmacovigilance, Safety Reporting, Regulatory affairs, FDA safety Reporting Portal. Show less

  • Drug Safety Associate

    Jun 2018 - May 2019

  • Drug Safety Associate E/L

    Oct 2017 - May 2018
• 

  ICON plc

  Jan 2020 - Sept 2021

  Drug Safety Associate | Lead

  Eudravigilance, Clinical trials & Post Marketing Reg Safety Reporting Specialities》Regulatory Safety Reporting Group Lead, perform project set up and maintenance, regulatory submissions. Perform reportability assessment for Clinical trials and Post Marketing ICSRs. 》Perform Expedited Reporting of ICSRs/SUSARs to European Medical Agency (EMA) via EVWEB Portal; perform the quality review and checking cases for discrepancies for any errors, compliance tracking and filing of cases.》Administer the entry and maintenance of product via Article 57, xEVMPD.》Perform registration and testing with national competent Authorities, Being a Responsible Person/Trusted Deputy ensure the completion of EudraVigilance Registration for Sponsors as per EMA requirements. Experienced in Gateway and WEBTRADER registration for sponsors as per the contract. 》Perform downloading of Individual case safety Reports and Medical literature Monitoring (MLM) searches. Perform Expedited Reporting of ICSRs/SUSARs to Medicines and Healthcare products Regulatory Agency (MHRA) via eSUSAR portal.》Liaises with Sponsors and attend project team meetings and teleconferences as required.》Ensure all the project specific, Client specific trainings are added to the learning plan of EudraVigilance Team, as a Subject Matter Expert (SME) worked to ensure all the trainings are up to date in the development path.》Responsible for coordination and collaboration with vendors servicing Safety projects 》Acts independently to manage safety responsibilities on study teams and in activities supporting safety reporting. Trains and mentors more junior members of the safety team》Takes on responsibility for more complex deliverables and takes on team leadership responsibility in order to manage and complete projects requiring more coordination and insight for low-medium priority projects》Perform triage and assessment of reportability of cases including literature cases for post-marketing projects in safety databases. Show less

• 

  PPD

  Sept 2021 - Oct 2022

  Safety Specialist

  PV Medical and Scientific Services; Centralized Literature Team》Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relavant and aggregate safety report-relavant safety information and analysis of similar events (AOSE) for both developmental and Market authorized products》Serves as a primary point of contact for low to medium complexity literature projects (e.g. Medium complexity projects with 1 to 5 products, projects involving review for ICSRs, Signal relavant, aggregate safety report-relavant safety information and AOSE, and projects with moderate to high volume of citation).》Review compliance for literature activities on assigned projects and escalate problems or issues》Prepare for and attend kick-off meetings and audits》Assist in setting up and maintenance of literature surveillance activities for assigned projects 》Maintain knowledge and understanding of PPD and client-provided SOPs and current regulations 》Responsible for adhering to organization policies, Standard Operating Procedures and Guidance Documents, and awareness of International Conference on Harmonisation-Good Clinical Practice (ICH GCP) guidelines and other relevant global and local regulations》Review and understands assigned study specific budgets》General understanding of pathophysiology and the disease process, more detailed knowledge of relavant therapy areas as required for literature Surveillance Show less

• 

  Thermo Fisher Scientific

  Dec 2021 - now

  Clinical Research Group; PV Medical and Scientific Services; Centralized Literature Team》Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relavant and aggregate safety report-relavant safety information and analysis of similar events (AOSE) for both developmental and Market authorized products》Serves as a primary point of contact for low to medium complexity literature projects (e.g. Medium complexity projects with 1 to 5 products, projects involving review for ICSRs, Signal relavant, aggregate safety report-relavant safety information and AOSE, and projects with moderate to high volume of citation).》Review compliance for literature activities on assigned projects and escalate problems or issues》Prepare for and attend kick-off meetings and audits》Assist in setting up and maintenance of literature surveillance activities for assigned projects 》Maintain knowledge and understanding of PPD and client-provided SOPs and current regulations 》Responsible for adhering to organization policies, Standard Operating Procedures and Guidance Documents, and awareness of International Conference on Harmonisation-Good Clinical Practice (ICH GCP) guidelines and other relevant global and local regulations》Review and understands assigned study specific budgets》General understanding of pathophysiology and the disease process, more detailed knowledge of relavant therapy areas as required for literature Surveillance Show less

  • Drug Safety Reporting Specialist III

    Jun 2024 - now

  • Drug Safety Reporting Specialist II

    Oct 2022 - Jun 2024

  • Safety Specialist

    Dec 2021 - Oct 2022