Disha Dutta
Winnipeg,Manitoba
Summary
Drug safety physician with more than 6 years of experience in pharmacovigilance. I am skilled at reviewing safety reports, including case narratives, adverse events, lab, drug, and medical history coding, determining seriousness, expectedness, and listedness, authoring company causality assessments, and requesting follow-up queries as part of assessing and reporting adverse events related to drug use. Solid understanding of FDA, EMA, and Health Canada regulations, the drug development process, and ICH-GCP principles. I have extensive knowledge of medical terminology, MedDRA (Medical Dictionary for Regulatory Activities), and the WHO drug dictionary. Adept at evaluating and presenting medical and clinical data in group discussions. Dynamic, detail-oriented team player with excellent communication and organizational skills.
Overview
15
15
years of professional experience
Work History
Committee Member
Clinical Biosafety Services
08.2023 - Current
- Attending all convened IBC meetings.
- Reviewing meeting materials in advance to determine whether the applicable criteria described in the NIH Guidelines are met.
- Staying current on biosafety literature, regulations, standards, and guidelines, as well as scholarly articles covering Human Gene Transfer.
Institutional Biosafety Committee Member
Advarra
06.2021 - Current
- Act in collaboration with IBC subject matter experts in the review of genetic engineering and gene therapy research to ensure the research is performed safely and in compliance with NIH Guidelines and other pertinent guidelines and regulations.
- Prepare and attend assigned meetings via videoconference.
- Review all submission materials and participate in relevant discussions during committee meetings, particularly as they relate to the community and the environment.
- Vote on each item presented to the committee.
Senior Drug Safety Physician
Apcer Lifesciences
07.2016 - 10.2020
- Managed daily assignments in conjunction with the manager for individual case processing, literature searches, aggregate reports generation, and performed other tasks relevant to the pharmacovigilance department, such as signal detection of adverse drug reactions with cases received for the client's products.
- Conducted case evaluations, causality assessments, and medical review of ICSRs in the pharmacovigilance database and aggregate reports for the purpose of expedited/periodic reports as per the regulations and SOPs (standard operating procedures).
- Responded to internal and external product information requests and medical queries pertaining to spontaneous ADR cases and literature cases as per the applicable SOPs.
- Generated and reviewed documents such as Standard operating procedures (SOP ) and Work
Instructions and ensured execution of the company's SOP. - Maintained awareness of changes to new FDA and EU PV regulations affecting PV (pharmacovigilance) activities
- Provided consulting services to clients and carried out necessary administrative duties.
- Ensured compliance to project guidelines and trained and mentored new employees.
Medical Reviewer/ Lead Physician, Oncology
Tata Consultancy Services
01.2014 - 06.2016
- Authored the Company Clinical Comment (CCC) for case reports that meet the SUSAR (Suspected Unexpected Rerious Adverse Reaction) criteria, edited the periodic report comment in the patient safety database, and provided documentation of the review and case comments in the Medical Review workflow.
- Conducted evaluations and assessments of case seriousness and causality and reviewed the medical sense of the ICSRs (Individual Case Safety Reports) in the global context of drug or clinical project, including the narrative, AE/SAE (Adverse event/Serious adverse event) terms, suspect drugs, concomitant medications, laboratory data, and medical history for all post-marketing, clinical trial, and literature cases.
- Assisted departments with medical opinions and responded to information requests such as product advice and coding guidance as per the standard operating procedures (SOPs).
- Handled KPI (Key Performance Indicator) findings and quality checks on ICSRs to detect data inconsistencies and provided suggestions for process improvement.
- Performed reconciliations by identifying coding errors and responded to data correction requests from marketing companies while using medical expertise.
- Performed daily internal quality checks for medical review on completed cases and discussed the findings with respective team members to help significantly decrease the number of critical field errors.
- Conducted RCA (Root Cause analysis) and CAPA (Corrective and Preventive Action) for late cases, which helped in improving the overall quality and adherence to internal submission timelines.
- Executed administrative duties such as maintaining data trackers, master product lists, arranging monthly team meetings, and preparing agendas and minutes of meetings in conjunction with the manager.
- Developed pharmacovigilance training materials and presentations.
- Mentored new team members and efficiently conducted ongoing training sessions for the medical review and case processing teams.
Resident Physician, Intensive Care Unit
Mahatma Gandhi Medical College and Hospital
08.2008 - 07.2009
- Provided medical care and treatment for life-threatening injuries and illnesses under the guidance of attending physician.
- Demonstrated care and compassion in explaining diagnosis, prognosis, and treatment to patients and family members.
- Assisted senior doctors with routine rounds and patient care, taking medical histories, conducting physical examinations, and writing notes.
Education
Certificate in Drug Safety and Pharmacovigilance Management and ICH-GVP -
Crown Medical Research and Pharmaceutical College of Canada
Toronto (North York), Canada08.2023
Clinical Research Management and Good Clinical Practice ICH-GCP (E6) -
Crown Medical Research and Pharmaceutical College of Canada
Toronto (North York), Canada07.2023
Master of Business Administration, Healthcare Management -
New York Institute of Technology
New York, USA12.2012
Bachelor of Medicine and Bachelor of Surgery (MBBS) -
Mahatma Gandhi Medical College And Hospital
Jaipur, India08.2008
Skills
- Case Processing
- Medical Review
- Causality assessment
- Medical Terminology
- Process Improvement
- MedDRA
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Timeline
Committee Member
Clinical Biosafety Services
08.2023 - Current
Institutional Biosafety Committee Member
Advarra
06.2021 - Current
Senior Drug Safety Physician
Apcer Lifesciences
07.2016 - 10.2020
Medical Reviewer/ Lead Physician, Oncology
Tata Consultancy Services
01.2014 - 06.2016
Resident Physician, Intensive Care Unit
Mahatma Gandhi Medical College and Hospital
08.2008 - 07.2009
Certificate in Drug Safety and Pharmacovigilance Management and ICH-GVP -
Crown Medical Research and Pharmaceutical College of Canada
Clinical Research Management and Good Clinical Practice ICH-GCP (E6) -
Crown Medical Research and Pharmaceutical College of Canada
Master of Business Administration, Healthcare Management -
New York Institute of Technology
Bachelor of Medicine and Bachelor of Surgery (MBBS) -
Mahatma Gandhi Medical College And Hospital
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