Kirat Kaur
Safety Writer
Melbourne,VIC
Summary
I am a globally focused healthcare professional with a little over 6 years of diversified experience in the Pharmacovigilance, involved in authoring and reviewing of various regulatory reports including PADERs, PBRERs, Health Canada Annual Summary Reports (ASRs), Adhoc reports, IND, SMPs, management of Individual Case Safety Reports (ICSRs) comprising of triage, registration, duplicate search, data entry, MedDRA coding and data validation of various case types (spontaneous, clinical studies, solicited programs and literature cases). I am well versed with ICH GCP guidelines, MedDRA, GVP modules and labelling documents.
Overview
9
9
years of professional experience
Work History
Safety Writer
Fortrea (Formerly Labcorp)
08.2024 - 12.2024
- Expertise in preparation/leading various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Adverse Drug Experience Reports, Periodic Benefit Risk Evaluation Reports, Development Safety Update Report, ACOs, Addendum reports, as assigned
- Author and review RMPs, adhoc reports, Benefit-Risk Evaluation reports, medical device reports
- Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned
- Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross-functional stakeholders in the management and tracking of such feedback
- Collaborate with GPS Medical physicians, scientists, pharmacoepidemiologists, and other personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy
- Interacting with client personnel to resolve issues in accordance with the client’s policies
Medical Writer I
Parexel International Services India Pvt Ltd
01.2024 - 07.2024
- Expertise in preparation/leading various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Adverse Drug Experience Reports, Periodic Benefit Risk Evaluation Reports, Development Safety Update Report, ACOs, Addendum reports, as assigned
- Author and review RMPs, adhoc reports, Benefit-Risk Evaluation reports, medical device reports
- Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned
- Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross-functional stakeholders in the management and tracking of such feedback
- Author/review manuscripts, abstracts, posters for conferences
- Responsible for leading various cross functional team meetings as well as liaising and collaborating with the relevant functions at the client’s end to facilitate the delivery of high-quality work
- Collaborate with GPS Medical physicians, scientists, pharmacoepidemiologists, and other personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy
- Expertise in independent QC of aggregate reports to ensure the information presented in the aggregate reports is complete, consistent, and compliant to Regulatory
- Mentoring of new starts in the team and provide training on the team process
- Interacting with client personnel to resolve issues in accordance with the client’s policies
Associate Medical Writer
Parexel International Services India Pvt Ltd
07.2021 - 01.2024
- Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross-functional stakeholders in the management and tracking of such feedback
- Author/review manuscripts, abstracts, posters for conferences
- Prepare medical information responses for HCPs
- Responsible for leading various cross functional team meetings as well as liaising and collaborating with the relevant functions at the client’s end to facilitate the delivery of high-quality work
- Collaborate with GPS Medical physicians, scientists, pharmacoepidemiologists, and other personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy
- Maintaining an awareness of the performance metrics measured by the client (where applicable) and starving to remain within established limits
- Maintaining an excellent knowledge of the safety profile of assigned drugs, reference safety information, aggregate reporting conventions and guidelines, client procedures and international drug safety regulation
- Interacting with client personnel to resolve issues in accordance with the client’s policies
Drug Safety Associate I
Parexel International Services India Pvt Ltd
07.2020 - 07.2021
- Experienced in literature triage as well as literature summarization for aggregate reports and Adhoc reports
- Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross-functional stakeholders in the management and tracking of such feedback
- Prepare medical information responses for HCPs
- Maintaining an awareness of the performance metrics measured by the client (where applicable) and starving to remain within established limits
- Mentoring of new starts in the team and provide training on the team process.
- Triage of ICSRs to determine whether they qualify for expediated reporting or not and the timelines within which they need to be submitted to the regulatory authorities.
Registration/initiation of ICSRs into the safety authorities. Conducting duplicates searches prior to registration and identifying potential duplicates Managing duplicate cases appropriately. - Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents (such as SPC, CDS, IB etc), writing case summaries, assessing causalities if required and writing company comment if required.
Pharmacovigilance Scientist
Parexel International Services India Pvt Ltd
11.2018 - 07.2020
- Triage of ICSRs to determine whether they qualify for expediated reporting or not and the timelines within which they need to be submitted to the regulatory authorities. Registration/initiation of ICSRs into the safety authorities. Conducting duplicates searches prior to registration and identifying potential duplicates Managing duplicate cases appropriately.
- Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents (such as SPC, CDS, IB etc), writing case summaries, assessing causalities if required and writing company comment if required.
Dental Surgeon
Patiala Poly Dental Clinic
03.2017 - 11.2018
- Diagnosis & treatment planning
- Various dental procedures
- Root canal treatment
- Digital radiograph
- Dental cleanings
- Composites, Amalgam restorations
- Prosthetic rehabilitations – complete dentures, removable partial dentures, fixed partial dentures
- Oral prophylaxis
- Major and minor surgical procedures
Intern
Civil Hospital
11.2015 - 02.2017
- Diagnosis & treatment planning
- Various dental procedures
- Root canal treatment
- Digital radiograph
- Dental cleanings
- Composites, Amalgam restorations
- Prosthetic rehabilitations – complete dentures, removable partial dentures, fixed partial dentures
- Oral prophylaxis
- Major and minor surgical procedures
Education
Bachelor of Dental Surgery - Dentistry
National Dental College And Hospital
India07.2015
12th Standard - Medical Science
Sri Guru Gobind Singh Senior Secondary School
India03.2010
10th Standard - High School
Sri Guru Gobind Singh Senior Secondary School
India01.2008
Skills
- Positive attitude towards work
- Strong analytical skills
- Team contribution
- Microsoft office
- Strong research skills
- Deadline attainment
- Idea brainstorming
- Content development
- Document editing
- Creative collaboration
Disclaimer
To the best of my knowledge and belief this resume correctly describes my qualification, my experiences and me.
Languages
English
Full Professional
Punjabi
Native or Bilingual
Hindi
Native or Bilingual
Interests
- Outdoor Recreation
- Gardening
- Hiking
- I like trying new recipes and food trends
Software
Argus
ArisGlobal
VeevaVault
Kofax
Timeline
Safety Writer
Fortrea (Formerly Labcorp)
08.2024 - 12.2024
Medical Writer I
Parexel International Services India Pvt Ltd
01.2024 - 07.2024
Associate Medical Writer
Parexel International Services India Pvt Ltd
07.2021 - 01.2024
Drug Safety Associate I
Parexel International Services India Pvt Ltd
07.2020 - 07.2021
Pharmacovigilance Scientist
Parexel International Services India Pvt Ltd
11.2018 - 07.2020
Dental Surgeon
Patiala Poly Dental Clinic
03.2017 - 11.2018
Intern
Civil Hospital
11.2015 - 02.2017
Bachelor of Dental Surgery - Dentistry
National Dental College And Hospital
12th Standard - Medical Science
Sri Guru Gobind Singh Senior Secondary School
10th Standard - High School
Sri Guru Gobind Singh Senior Secondary School
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