Dr.Divya Kallingal
Medical Safety Expert (MRQC)
Hyderabad
Summary
Dedicated Pharmaceutical Physician with history of meeting goals by utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand and simultaneously improving personal knowledge and skills.
Overview
4
4
years of professional experience
6
6
years of post-secondary education
6
6
Languages
Work History
Medical Safety Expert (MRQC)
Novartis
Hyderabad
01.2021 - Current
- Process Owner for As Determined Causality Assessment and Medical assessment comment (ATT- 8103846 to WP- 8036830)
- Business lead for Argus optimization- Auto causality
- Check quality of medical review of safety cases for Novartis portfolio in safety database.
- Contribute to development and implementation of quality metrics for medical review of safety cases.
- Contribute to CMO&PS initiatives as well as cross-functional projects to optimize medical review processes and quality
- Contribute to development and optimization of training materials. Deliver training to Novartis staff and external service providers.
- Contribute to optimization of processes used to monitor quality of medical review of medicinal products and medical devices according to business rules, guidelines and standard operating procedures, and ensure quality of deliverables are met:
- Generate knowledge by means of trend analyses and work jointly with external vendors, Compliance & Risk Management, Vigilance Quality Excellence, Vigilance Process Excellence and other groups to address and resolve any identified gaps.
- Review feedback and respond to Health Authorities requests or other external parties, which is within scope of responsibilities, and integrate feedback to maintain Novartis group standards, as appropriate.
- Act as during audits and inspections, contribute to preparation of responses to findings and development, implementation and sustainability of CAPAs.
- Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to meet joint accountabilities.
- Support the Head MSO Quality and Compliance to determine quality review strategy and set objectives for the Quality & Compliance team.
- Deputize for Head MSO Quality and Compliance as appropriate.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Prepared variety of different written communications, reports and documents.
Safety Physician / Associate Medical Manager PSS
Covance Inc.
Pune
07.2020 - 01.2021
- Undertake primary medical review of cases, including medical assessment of case for seriousness, listedness /labeling, causality, adverse event coding and narrative review
- ICSR management of Clinical trial cases (Medical review, AOSE [analysis of similar events] analysis and drafting, Investigator Cover letter drafting.
- Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.
- Assume complete responsibility for all assigned deliverables in line with expected quality, compliance and productivity SLAs and KPIs.
- Undertake and complete additional tasks/activities, assigned by supervisor, as required.
- Provide training and guidance to case processing team on medical aspects of case processing.
- Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
- Ensure compliance of operations with governing regulatory requirements.
Drug Safety Physician
Bioclinica Pvt. Ltd.
Mysore
02.2019 - 06.2020
- Conducted medical review, assessment and triage (to determine seriousness at case intake level as required) of individual case safety reports obtained and routing cases to approval activity.
- Assigned appropriate MedDRA codes and assessed, causality and labeling.
- Medical review of Clinical trial cases.
- Reviewed narrative and provided company comment in accordance with client requirements
- Escalated complex case issues on client product(s) to Team lead/ Associate Project manager as appropriate.
- Identified and resoled issues by coordinating with client therapeutic teams/site for specific products or functional groups
- Communicated and interacted effectively within and across all client therapeutic teams, and within functional team management as appropriate
- Performed any other drug safety related activities as assigned (eg: ICSR reconciliation from DSUR).
- Performed medical approval of non-serious cases.
- Tracked and managed Key Performance Indices of medical review team to help maintain quality standards of project.
- Performed Error Analysis for defaulted cases and cascaded assessed information to team effectively
Resident Medical Officer
Fortis Clinical Research Ltd.
Mumbai
05.2017 - 04.2018
- Provided routine and emergency medical care to patients.
- Performed initial assessment on admission/ re- assessment as needed
- Prepared discharge summaries and explained post discharge instructions to patients and their attenders
- Collected detailed anamnesis of patients and conducted basic and thorough physical examination
- Discussed evaluation with consultant physician/ surgeon and helped assign treatment protocol
- Carried out orders, suitable investigations including electrocardiography, and other radiological and laboratory analysis
- Performed minor procedures like paracentesis, thoracocentesis, central venous catheter insertions, urinary catheterization, ABG (arterial blood gas), phlebotomy and other sample collection (and interpretation) and other minor procedures as directed by consultants
- Assisted in surgeries and performed minor surgical procedures.
- Performed daily ward rounds- Attended patients, making note of progress in clinical condition of patient, and in lab investigations and updated treatment as per guidance of attending physician accordingly.
- Certified death and issued certificates.
Education
M. D. Physician - Medicine
Odessa National Medical University
Odessa, Ukraine 09.2010 - 06.2016
Skills
Medical review and ICSR management
Efficiency of quality check of medical review of safety cases
Metrics preparation and review process
Experience with relevant safety database (ARIS-g 74, Argus 812)
MedDRA Coding
Knowledge of the Pharmacology, products for human exposure, Life Sciences, Industry and Lifecycle of Drug Development
Microsoft office (excel, PowerPoint, word, outlook)
Timeline
Medical Safety Expert (MRQC)
Novartis
01.2021 - Current
Safety Physician / Associate Medical Manager PSS
Covance Inc.
07.2020 - 01.2021
Drug Safety Physician
Bioclinica Pvt. Ltd.
02.2019 - 06.2020
Resident Medical Officer
Fortis Clinical Research Ltd.
05.2017 - 04.2018
M. D. Physician - Medicine
Odessa National Medical University
09.2010 - 06.2016