Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Additional Information
Timeline
Generic

Shoumik Roy

Burnaby,BC

Summary

Dedicated healthcare professional with 6+ years of experience and a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Health care worker

Classic Lifecare
04.2022 - Current
  • Completed and submitted 50+ clinical documentation in accordance with agency guidelines.
  • Supported diagnostic and technical treatment procedures such as setting up and operating special medical equipment and apparatus.
  • Partnered with healthcare teams to address care plan management, development, and implementation.
  • Completed necessary reports and documentation on time and to specifications.
  • Diagnosed issues and implemented treatment plans to resolve problems or help manage symptoms.
  • Met with patients to discuss medical histories and current complaints.
  • Reviewed patient allergies, problems, medications, and immunization statuses.
  • Inspected equipment for defects and completed basic repairs.
  • Supported office operations by expertly handling administrative needs.
  • Conducted physical assessments of relevant body areas and performed standardized tests to check responses.
  • Implemented therapeutic regimens involving medications and other interventions to mitigate symptoms and prevent reoccurrence.

Front End

Loblaw Inc, RCSS
10.2022 - Current
  • Monitored checkout stations to ensure that adequate cash and are staffed appropriately.
  • Compile and maintain non-monetary reports and records.
  • Confer with customers by telephone or in-person to provide information about products or services, and to obtain details of complaints.
  • Controlled shrinkage to 1.44% through successful inventory management and stock rotation strategies.
  • Monitored cash drawers in 8 checkout stations to verify adequate cash supply.
  • Responded to customer concerns with friendly and knowledgeable service and remedied issues promptly and effectively.
  • Strengthened merchandising and promotional strategies to drive customer engagement and boost sales.
  • Managed customer service duties by greeting over 100 customers daily and informing customers about products.
  • Completed stockroom tasks by leading stock team, receiving and unpacking merchandise and placing all products out on sales floor.

Consultant/Drug safety scientist

ESS Life sciences(United therapeutics)
12.2018 - 10.2020
  • Performed duties as Regulatory Submission Specialist which include reporting and submission of adverse events due to medications, medical devices, and product problems to health authorities (USFDA, Health Canada, EMA), institutional review board, ethics committees, safety partners, and investigators to ensure safety of volunteers/patients involved.
  • Tested more than 80 reporting rules and regulations for different regulatory destinations worldwide as per ICH requirements.
  • Supported clients with business analysis, documentation, and data modeling.
  • Developed hands-on experience with new process start-ups and Business continuity plans and initiated and implemented these twice in critical unplanned events.
  • Maintained and executed Corrective and preventive action (CAPA) and deviations in order to reduce errors by 75% in drug safety cases
  • Participated in weekly CAPA board reviews, and monthly quality reviews, and plan daily operations to meet 95% SLA target.
  • Review and evaluate implications of key scientific publications and payer policies.
  • Draft, edit, and deliver results and findings relevant to internal and external stakeholders: e.g., abstracts, posters, manuscripts, value dossiers, proposals, and presentations.

Drug Safety Associate

Syneos health group
02.2017 - 12.2018
  • Performed nullification, duplicate case detection, and master case updates for safety cases in EV WEB database to facilitate the signal detection process for European medicines agency.
  • Coded suspect and concomitant drugs using company and WHO-DRUG dictionaries
  • Performed literature search, market research, and trends to determine consumer demand.
  • Convergent with global safety database ‘ARGUS’, DD-client–Eudravigilance, EV-WEB.
  • Interacted with stakeholders to discuss ongoing projects and maintain workflow and timelines.
  • Performed registration of initial and follow-up information with HCP for cases in the safety database which include duplicate checks, and entry of minimal information into safety database according to the prescribed work instructions.
  • Maintained necessary peer-client communication related to case processing.
  • Initiated process and operational improvement leading to better project turnaround time, a reduction in resource wastage by 50%, and improved client satisfaction.
  • Presented research findings to scientific audience and general public.
  • Communicated with internal or external contacts to resolve issues related to case processing.
  • Reviewed ancillary documentation to identify information for processing and electronic capture.
  • Prioritized Fatal ICSR and SUSAR clinical trial deliverables to accomplish work in established timeframes.
  • Navigated intricacies of drug safety databases to process adverse event reports.

Drug Safety Officer

Wipro BPS, Pfizer
10.2015 - 02.2017
  • Involved in tasks in compliance with the United States FDA and cooperation with clients.
  • Implemented and maintained safety data exchange agreements and transmission and reconciliation of pharmacovigilance ICSR as per PVA agreements.
  • Managed expedited ICSR and aggregate reporting timelines on ‘ARGUS’
  • Exchanged the documents and notification to licensing partners/other companies as per Pharmacovigilance agreements.
  • Performed follow-up activities with HCP, non-HCP, and other companies.
  • Performed cases related to regulatory authorities, splitting of cases, at-risk scenarios, lack of efficacy, mother-fetus, and other E2b-linked reports.
  • Acted as data migration officer and was responsible for full data Entry in the migration data entry workflow step in accordance with report from mapping instructions Into Oracle Argus.
  • Reviewed any address errors/warning messages, e2b validation errors.
  • Checked for the duplicate booked-in into the system in the appropriate data migration workflow
  • Acted as a quality reviewer and was responsible for quality migration review/ peer-review workflow step based on instructions in a report from Pfizer mapping documents to meet 98% SLA .
  • Ensured the event term selection, coding, and verbatim narrative as per the MedDRA and forwarded quality-reviewed case for medical assessment.
  • Examined Pfizer medications for defects or issues, reported problems quickly, and maintained high levels of accuracy.
  • Worked flexible hours; night, weekend, and holiday shifts.
  • Demonstrated respect, friendliness and willingness to help wherever needed.

Education

MBA - Business Administration

Vancouver Island University
Nanaimo, BC
11.2022

Masters in Pharmaceutical Science - Quality Assurance

Sardar Patel University
07.2014

Bachelors in Pharmaceutical Science -

Amity University
07.2012

Skills

  • Computer Proficiency
  • Project management
  • Handling Complaints and Inquiries
  • Reporting and Performance Analysis
  • Effective Working Relationships
  • Corrective Actions
  • Regulatory and Legal Compliance
  • Adaptable to Changing Demands

Accomplishments

  • Achieved a merit rank of 135 in the C.E.T exam for Pharmacy.
  • Used Microsoft Excel to develop a worldwide Regulatory reporting tracking spreadsheet.

Certification

Acadgild Data Analytics with R and Tableau.

Additional Information

Publication:

Patel, B., Roy, S., Ghelani, H., & Parmar, S. (2017). Development & validation of RP-HPLC method for estimation of Dabigatran etexilate mesylate from capsule dosage form. International Journal of Pharma Sciences and Research, 143-151.


Academic Projects:

Financial Analysis of International flavors and fragrances Inc.(IFF).

  • Conducted trend analysis by using Dupont framework and studied the past 5 year's performance of the company and its competitors.
  • Calculated the working capital and cash conversion cycles to identify the loopholes that impacted the inventory, receivables, and payables turnover ratio.

Applied Business project on Pricing of pharmaceuticals.

  • Performed a budget Impact model analysis from a meta-analysis using secondary research from various publications and authors.
  • Applied literature search within the scope of MEDLINE(PubMed) and Embase.
  • Analyzed and applied research on the understanding of increasing prices of drug products in Canada and studied the optimization of prices through the Health economics principles, discounted cash flow, and cost-effective models.

Timeline

Front End

Loblaw Inc, RCSS
10.2022 - Current

Health care worker

Classic Lifecare
04.2022 - Current

Consultant/Drug safety scientist

ESS Life sciences(United therapeutics)
12.2018 - 10.2020

Drug Safety Associate

Syneos health group
02.2017 - 12.2018

Drug Safety Officer

Wipro BPS, Pfizer
10.2015 - 02.2017

MBA - Business Administration

Vancouver Island University

Masters in Pharmaceutical Science - Quality Assurance

Sardar Patel University

Bachelors in Pharmaceutical Science -

Amity University

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