KAJAL SANKHE
25/59,Spring Street,Onehunga,AUK
Summary
Dynamic and detail-oriented drug safety specialist with five years of progressive experience in pharmacovigilance, regulatory compliance, and team management. Demonstrating expertise in handling diverse case types, reviewing and coding medical data, and ensuring strict adherence to global safety regulations, including Health Canada, FDA, and EMEA guidelines. Adept at leading teams, improving quality metrics, and implementing strategic initiatives to enhance efficiency. Recognized for outstanding performance with multiple awards, including the "Star of the Month" and "Best Team Award." Passionate about delivering high-quality results in a collaborative and fast-paced environment.
Overview
7
7
years of professional experience
Work History
DRUG SAFETY SPECIALIST +
TATA CONSULTANCY SERVICES
06.2022 - 09.2024
- Knowledge of the Pharmacovigilance industry including up-to-date knowledge of; pharmacovigilance guidelines of Health Canada, US FDA, EMEA, and ICH
- Experienced in handling types of cases (Spontaneous, Solicited, Pregnancy cases, and Interventional/Non-Interventional study cases)
- Identify case-related information including medical conditions, lab results, and procedures, as well as compile a full narrative summary paragraph
- Review data to ensure case accuracy with minimal error in narratives
- Review MedDRA and WHODrug coding as needed
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
- And Serve as a resource for investigational sites
- Implemented strategies to decrease key fields error and late case form KPI files and maintain target by up to 90%
- Monitor and manage safety inbox including archiving of emails and documents
DRUG SAFETY SPECIALIST
TATA CONSULTANCY SERVICES
02.2021 - 05.2022
- Reviewed and Supervised 1000+ articles correctly
- Increased quality by 95% every year, achieving 100% productivity
- Additionally, reviewed and investigate clinical trial cases and articles
- Managed a team of 15 members and delivered an excellent performance
- Experience in audit and client meetings face-to-face and introduced the meeting plus taking training of the new Joiners
- Coordinated through activity and effectiveness-based training
- Update and manage various Workflows as well as submission trackers
- Initiates and conducts follow-up activities related to local ADR reports
DRUG SAFETY ASSOCIATE
TATA CONSULTANCY SERVICES
11.2020 - 01.2021
- Brief knowledge of Coding, Possessing expert knowledge of drug safety databases like well-known argus and Sapphire Database and for review purposes used Embase and Insight Memes
- Review triage assessments and monitor the incoming reports and perform case management including receipt, duplicate check, book-in, assessment of seriousness and expectedness, data entry, and auto-narrative writing
- Correctly identify cases requiring targeted follow-up, determine relevant follow-up queries, and Meet specific data and 100% quality targets and production for case handling
DRUG SAFETY ADMINISTRATOR
TATA CONSULTANCY SERVICES
10.2019 - 12.2020
- Initial and Follow-up information for individual adverse event case reports of the global Patient Safety database (such as book the case and add to the database) and seek the physician assessment and causality as per source
- Implemented data interpretation, coding, and writing skills in accordance with the current Data Entry Process as per guidelines of Pharmacovigilance
- Instructions and a Better understanding of Jasper, CIOMS, Health Canada cases, European Union regulations and guidelines, and good clinical PV practices (GVP)
- Maintains high compliance standards with reporting timelines and quality of local adverse drug reactions (ADR) data
REGISTERED PHARMACIST
KAWLI MEDICAL STORE
09.2019 - 10.2020
- Assisted in Dispensing medications accurately according to prescription and ensuring patient safety.
- Helping the patients choosing over-the-counter (OTC) products and inform about the side effects and interactions with other drugs.
- Provided the proper guidance by counseling patients regarding health issues and concerns on medication usage, potential side effects and interaction with food or other drugs.
- Maintain patient privacy and update the records of each patient in the system.
- Maintained and managed inventory of medicines, ensuring availability and proper stock rotation to avoid expiries.
- Ensured compliance with all pharmacy regulations and maintained accurate documentation of prescriptions and sales.
- Built strong relationships with patients through effective communication as per their understanding.
- Patiently managed to work in Covid-19 pandemic to raise awareness in the patient regarding the vaccine and how to get not infected.
- Stayed updated with the latest pharmaceutical products, guidelines, and drug interactions for the patient safety.
- Ensured cleanliness and organized storage of medicines and equipment in the pharmacy.
GRADUATE INTERN PHARMACIST
KAWLI MEDICAL STORE
06.2019 - 09.2019
- Training regarding how to read prescription(hand written by doctors) and ask the patients requires more clarification of the drugs.
- I received training maintaining the patient confidentiality like patient history and other details and kept as record in digital and Non-digital form.
- Managing prescriptions and daily pharmacy duties.
- Under the guidance of Senior Pharmacist i have assisted in dispensing medications to patients as per prescriptions along with handle the queries regarding medication usage and side effects.
- I have counsel the patients and given advice under the guidance of supervision.
- In training period, i learned how to storage the medication as per pharmaceutical guidelines.
- I received training how to maintain the medicine record and how to maintain the stocks or medicine and other healthcare products.
- Provided advice on over-the-counter (OTC) medications for common health conditions.
- Learned about pharmacy compliance and regulations.
TRAINEE
BLISS GVS PHARMA
06.2017 - 08.2017
- I had the opportunity to apply and expand my academic knowledge in a real-world pharmaceutical setting. I was involved in various aspects of the company's operations, including assisting in the development and testing of pharmaceutical formulations, conducting stability studies, and analyzing raw materials and finished products to ensure quality and compliance with industry standards. I also worked closely with the research and development (R&D) team, gaining hands-on experience in laboratory techniques such as high-performance liquid chromatography (HPLC) and dissolution testing. Additionally, I participated in the preparation of regulatory documents, ensuring that all procedures and product formulations adhered to local and international regulations. This experience not only strengthened my technical skills but also provided valuable insights into the complexities of the pharmaceutical industry, from production to quality control and regulatory affairs.
Education
BACHELOR - PHARMACY
SINHGAD INSTITUTE OF PHARMACEUTICAL SCIENCE
UNIVERSITY OF PUNE06-2019
Skills
- Team-oriented
- Planning and Coordination
- Training and Development
- Leadership
- Decision-Making
- Detail-orientated
- Self-motivated
- Multitasking
Software Knowlegde
- Saphhire/ARiSg
- Oracle Argus Database
Languages
ENGLISH
HINDI
MARATHI
Accomplishments
- Star of the Month Award in 2021
- Service and Commitment Award in 2022
- Best Team Award in 2023
- Best Mentor Award
- Star of the Month award in 2023
- Star of the Month Award in 2024
- Best KPI Specialist in 2024
Internship
TRAINEE, BLISS GVS PHARMA, PALGHAR, 06/17, 08/17
Timeline
DRUG SAFETY SPECIALIST +
TATA CONSULTANCY SERVICES
06.2022 - 09.2024
DRUG SAFETY SPECIALIST
TATA CONSULTANCY SERVICES
02.2021 - 05.2022
DRUG SAFETY ASSOCIATE
TATA CONSULTANCY SERVICES
11.2020 - 01.2021
DRUG SAFETY ADMINISTRATOR
TATA CONSULTANCY SERVICES
10.2019 - 12.2020
REGISTERED PHARMACIST
KAWLI MEDICAL STORE
09.2019 - 10.2020
GRADUATE INTERN PHARMACIST
KAWLI MEDICAL STORE
06.2019 - 09.2019
TRAINEE
BLISS GVS PHARMA
06.2017 - 08.2017
BACHELOR - PHARMACY
SINHGAD INSTITUTE OF PHARMACEUTICAL SCIENCE
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