Ankitha K A Email & Phone Number

Process Expert with 7 years of extensive experience in pharmaceutical/ Medical device industry. Also working as a regulatory response coordinator for Health Authority inquiries.• Receive inquiries from Health Authorities regarding previously submitted adverse event/vigilance reports or general safety inquiries.• Open task records to document all new HA inquiries, escalate as necessary, and coordinate the collection of information/data necessary to respond.• Review draft response components to ensure readiness of the response draft for final review.• Facilitate final review process for proposed HA responses.• Distribute timely approved responses to local submitters or submit responses directly to requesting HA, as needed, documenting accordingly.• Schedule strategy meetings to determine response approach and final review meetings, as needed.Expertise in data entry/data analysis experience with Argus and working as a SME on case processing.Working on ARGUS database and involved in ICSR processing which includes legal cases, literature cases, spontaneous cases, license partner cases, non-interventional studies cases and literature cases. Case intake process: Triaging for spontaneous cases, clinical trial cases, legal cases and license partner cases, separation of cases into Critical and Non-critical cases for case processing team as per timeline. Knowledge on Case Processing which includes Case Triage, initial and follow up data entry, Duplicate check, narrative writing, MedDRA codings and performing Labelling / Listedness and Causality determination.Assessment of case reports for seriousness, causality and expectedness.Well versed in Pharmacovigilance concepts including MedDRA, WHO-DD coding, ICH/GCP principles and Pharmacovigilance regulatory requirements.Being as a QCer, responsible for performing the quality check of the case.Work closely with physicians in medical evaluation of cases and assessing expectedness.Review of Source Document, Expedited report processing, Narrative Writing, Dossier preparation, Query creation, follow-ups and preparing backlog for all the Medical device studies. Mentoring the mentees for various Medical device studies. Worked as a back-up lead for specific health and patient characteristics to understand the indication for Transapical- Transcatheter aortic valve implantations.Handled multiple Medical device studies at a time (4 studies).Worked on ARGUS, Medidata rave, Medrio database, SAS database and iflex application.

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  Rajiv Gandhi University Of Health Sciences

  Pharmacy