Experience

DDReg Pharma
• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• General Manager, Pharmacovigilance

  • Jul 2022 - Present


Syneos Health (Previously INC Research/inVentiv Health)

• Sr Safety & PV Specialist

  • May 2019 - Jun 2022

  Rresponsible for the preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators, adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs. Responsible for providing delivery and expertise with minimal oversight. Coordinates workflow to ensure delivery of project/program. Accountable to the Project Lead at the project/program level and line manager for deliverables. Show less



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance Safety Specialist II

  • Apr 2017 - May 2019

  Performs all aspects of the collection, processing, and reporting of adverse events/endpoints adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines and study procedures. May lead one or several projects of moderate to high complexity. Performs all aspects of the collection, processing, and reporting of adverse events/endpoints adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines and study procedures. May lead one or several projects of moderate to high complexity.


APCER PHARMA
• United Kingdom
• Retail Office Equipment
• 1 - 100 Employee
• Senior Pharmacovigilance Associate

  • Aug 2013 - Mar 2017

Ranbaxy R & D
• Medical writer

  • Nov 2012 - Aug 2013


Auriga Research Ltd

• India
• Research Services
• 100 - 200 Employee

• Research Coordinator

  • Mar 2012 - Sep 2012

  Clinical Operation: Providing assistance in Volunteer Screening Process, Obtaining of Informed Consent from the volunteers, Monitoring of clinical Studies to ensure that the study is conducted in compliance with approved protocol, GCP, relevant SOPs and applicable regulatory requirements, Quality analysis of the data generated during the study. Medical Writing: Designing and review of Study Protocol, Investigator’s Brochure (IB), Informed Consent Document (ICD), Case Report Form (CRF), and Preparation of clinical study report as per ICH E3 guidelines Designing of Clinical Expert Reports, Maintenance of Trial Master File. Quality Assurance: To conduct regular study audits. To impart training to all personnel in the facility including the newly appointed staff, permanent and contractual staff of the CRO. To maintain the training records of the personnel. To update and maintain Sop’s in proper files. To ensure availability of raw data forms and logbooks. To ensure an adequate and safe working environment within CRO. Clinical Trails: Handling Vaccine Trail-Pseudovac Generation of essential research documents, Verification of CRFs against the source documents. To oversee the progress of the study at the site, to check compliance with protocol, GCP/ ICH Guidelines and other applicable regulatory requirements and providing assurance of good site performance ensuring quality in the trial. Manage Regulatory Authority applications & approvals. Show less