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Work Background
Associate Director Solution Consulting
Nurocor, IncAssociate Director Solution Consulting
Nov. 2023 - Jan. 2025
Senior Consultant (R&D)
Veeva SystemsSenior Consultant (R&D)
Mar. 2023 - Jul. 2023Budapest, Hungary
Consultant
Veeva SystemsConsultant
Jan. 2021 - Mar. 2023Budapest, Hungary
Team Manager (Aggregate reports)
BioclinicaTeam Manager (Aggregate reports)
Mar. 2018 - Aug. 2019India-Managed aggregate report team, implemented training programs. -Quality review of reports (PBRER, PSUR, ACOs, HA request). -Co-ordinated project audits. -Assessment of team performance metrics.
Business Process Lead (Oncology)
Tata Consultancy ServicesBusiness Process Lead (Oncology)
Nov. 2016 - Mar. 2018Mumbai, Maharashtra, India-Team supervision -Developing Business process SOPs -Defining Industry best practices -Identify project risks and devised mitigation strategies -Building strong customers relationships -Driving Business process efficiency improvement initiatives.
Senior Drug Safety Specialist - Lead Medical Writer
PAREXELSenior Drug Safety Specialist - Lead Medical Writer
Apr. 2014 - Nov. 2016India- Senior Project Lead - Developed project solutions to meet broad array of deliverables. - Quality document management. - Co-ordinated internal and external audits.
Drug Safety Specialist- Medical Writer
Quantum Solutions IndiaDrug Safety Specialist- Medical Writer
Dec. 2011 - Apr. 2014India- Clinical Study Reports (CSR) Narrative writer and quality reviewer. - Development of CSR narrative templates and training team on clinical protocols and eCRF - Assessment of medical information - Retrieval of outputs from databases like Oracle, JReview, Spotfire, ARGUS, ARISg and MedDRA. - Comprehensive experience with ICH and GXP guidelines - Conducted training and change management processes to improve operations. - Trained on clinical trial documents including clinical trial protocols, case report forms (CRF/eCRF), consent forms, and clinical study reports (CSR).

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