Deeksha Zadoo

Experience

• 

  IDS Infotech Limited

  Nov 2013 - Jan 2014

  Associate I&A-Trainee

  Indexing & Abstracting of articles and research papers

• 

  Gen-X Diagnostics

  Nov 2013 - Nov 2013

  Traniee

  Training in Molecular Biology Techniques (Real-Time PCR & FACS)

• 

  Codon Biotech Pvt. Ltd

  Nov 2014 - Jan 2016

  Working on a project titled "Studies On Bioconversion Of Glycerol, A Byproduct Of Biodiesel Industry Into Economically Important 1, 3 Propanediol".Executing industry-specific training for biotech students in various disciplines of biotechnology. Working on biofuel production.

  • Junior Research Fellow

    May 2015 - Jan 2016

  • Project Trainee

    Nov 2014 - Apr 2015
• 

  PharmaLex

  Apr 2016 - May 2017

  Drug Safety Specialist

  ▪ Processing of individual case safety reports (ICSRs).▪ To perform the check reply of cases.▪ Monthly reconciliation of check reply.▪ Documentation of case processing at case level.▪ To co-operate with Medical Advisors while case processing.related to adverse event (AE) and adverse drug reaction (ADR).▪ To organize and participate in internal project organization meetings.

• 

  Panacea Biotec Ltd.

  Jun 2017 - Aug 2018

  Pharmacovigilance Specialist

  -Assist in preparing periodic safety-update reports; ensures its timely submission and further archiving.▪ Conduct follow up activity of spontaneous ADR reports, medical inquiry/product complaints with doctors, marketing team or respective reporters. ▪ Reporting of serious/non-serious ICSRs to regulatory authorities as per national and international reporting requirements. -Oversee and coordinate with contract research organizations (domestic market) and international partners for carrying out pharmacovigilance activities.▪ To assist manager in imparting pharmacovigilance training to staff members and associates (training sales and marketing team for carrying out the pharmacovigilance activity for the company related different marketed products).▪ Conduct monthly/quarterly/annual reconciliation with business partners. Show less

• 

  PPD

  Sept 2018 - now

  • Working as Global Study Lead for different projects including clinical trial and post marketing studies. Capable of coordinating and managing a global study including initial study set up, interim process, and study closure.•Responsible for the overall drug safety operations, including the management of Serious Adverse Event (SAE) processes for several projects.• Actively support APAC region - New hire and ARISg training .• Oversee expedited reporting and assist staff as needed.• Developed and maintained safety database DEGs, and project specific SMPs.• Closely collaborate with Data Management on SAE reconciliation between the clinical/safety database(s)• Review compliance of expedited safety reporting on assigned projects and escalate problems or issues to PVG Manager• Provide project specific safety training to PPD Clinical on assigned projects.• Assist with preparation and review of regulatory reports.• Review literature articles/abstracts and process adverse event reports from literature per program a• Participated in internal and client audits. Show less •Responsible for the overall drug safety operations, including the management of Serious Adverse Event (SAE) processes for several projects.• Actively support APAC region - New hire and ARISg training .• Oversee expedited reporting and assist staff as needed.• Maintain knowledge and understanding of PPD SOPs; current local and global regulations regarding clinical trials, regulatory documents and safety issues.• Effectively interface with project teams, Client Company, and Investigators regarding safety activities from project start-up through database lock.• Developed and maintained safety database DEGs, and project specific SMPs.• Closely collaborate with Data Management on SAE reconciliation between the clinical/safety database(s)• Ensure any expedited safety reports are notified to applicable Regulatory Authorities, Ethics Committees and Principal Investigators within regulatory timelines.• Review compliance of expedited safety reporting on assigned projects and escalate 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, case processing into PPD-owned or client provided adverse event database, peer 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.• Assist with preparation and review of regulatory reports.• Review literature articles/abstracts and process adverse event reports from literature per program and regulatory requirements.• Participated in internal audits. Show less

  • Lead Safety Specialist

    Apr 2021 - now

  • Safety Specialist

    Sept 2018 - Mar 2021