Debika Das

About Debika Das

Currently I am working as Drug safety specialist at PAREXEL International and holding 7+ years of experience in Pharmacovigilance in case processing programs with multiple clinical trial and post-marketing programs from India. I have been worked on multiple safety databases including ARISg (7.4) and Argus (7.0). In addition to Safety databases, I have equally got exposure for exploring Electronic Data captures (EDCs) and RAVE. • Knowledge of US and ICH safety reporting regulations and guidelines. • Good knowledge in monitoring and tracking Serious Adverse Events, serious and non-serious adverse drug reactions, and other medically related project information. • Processed fatal, serious, non-serious cases in ARGUS and ARISG • Good knowledge in Literature search for adverse drug reactions related to drugs. • Proficient in data entry and drug safety database. • Excellent written and verbal communication skills. • Good interpersonal, organizational skills and analytic thinking. • Demonstrated ability to work with MS Office products such as Word, Excel, Access and Powerpoint. Specialties: Pharmacovigilance and Clinical Research.

Experience

1. Senior Drug Safety Associate

   ICON plc

   Jul 2021 — Present

   Individual Job Role• Prepare regulatory documentation packets and coordinate the timely completion and submissionof required reports to Health Authorities, ethics committees, Principal Investigators, and businesspartners.• Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.• Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safetyinformation.• Ensure the completion of all departmental project activities accurately in accordance with ICONstandards, regulatory requirements, and contractual obligations to sponsors.Operational Role• Provide quality and process training to the associates/ team, Managed the workflow includingresource allocation, Project initiation, and conduct team hurdles to improve quality including Clientquery management.• QC of CT cases, Spontaneous, PMS, and Literature cases

Education

• Utkal University

  Bachelor's degree

  2007 — 2011

• Utkal University

  Master's degree

  2011 — 2013

Skills

• Pharmaceutical Industry
• Case Management
• Regulatory Affairs
• Standard Operating Procedure (Sop)
• Pharmacovigilance
• Case Processing
• Regulatory Submissions
• Arisg