Hiral Gosai
Maple,ON
Summary
Drug Safety Specialist supporting case processing for spontaneous and clinical trial reports across marketed and investigational products. Handles triage, narrative writing, quality review, coding in MedDRA and WHO-DD, and timely submissions to regulatory authorities while resolving queries and improving case completeness.
Overview
1
1
Certification
11
11
years of professional experience
Work History
Drug Safety Specialist
MediPharmSolutions
08.2024 - 09.2025
- Reviewed spontaneous reports and clinical trial cases for marketed and investigational compounds to determine regulatory reporting responsibilities
- Processed serious adverse event information per sponsor's standard operating procedures and submitted ICSRs to regulatory authorities within compliance timelines
- Determined the reportability of cases to local and international regulatory authorities and ensured timely submissions
- Oversaw case triage, data entry, narrative writing, and quality review to ensure accurate and compliant reporting
- Conducted quality reviews for AEs, SAEs, and SUSARs
- Created queries to obtain missing case information, enhancing the completeness of safety assessments
- Leveraged organizational and teamwork skills to ensure compliance with regulatory requirements and maintain high-quality outputs
- Performed medical coding using MedDRA and WHO DD
- Coded adverse event terminology and other medical information in the safety database as per coding policies and standards
- Reconciled safety event queries with the data management team promptly.
Senior Sandwich Artist
Subway Restaurant
03.2015 - 11.2018
- Helped customer satisfaction and team efficiency as a senior sandwich artist through fast service, quick response, and reliable food prep.
- Improved customer satisfaction by preparing quality sandwiches and keeping the work area clean.
- Built strong rapport with regular customers through engaging conversation and personalized service based on preferences.
- Boosted sales through upselling and suggesting popular menu items.
- Processed orders quickly and accurately through the point-of-sale system while keeping interactions friendly.
- Helped with cash handling, including register opening, register closing, cash drawer balance checks, and timely deposits.
- Operated the cash register.
- Assisted in training new staff on sandwich preparation and customer service.
- Supported staff training by sharing sandwich crafting techniques, product knowledge, and company policies.
- Followed health and safety rules, handled food properly, and backed team members while resolving issues early.
- Maintained food safety compliance through strict sanitation and cleanliness practices in sandwich preparation and handling.
- Implemented sanitation practices to comply with health regulations.
- Conducted quality checks to ensure products met company standards.
- Kept product quality consistent by reviewing company standards and adjusting sandwich prep methods as needed.
- Oversaw inventory levels to ensure adequate stock for operations.
- Reduced food waste through careful inventory management and freshness monitoring.
- Monitored spending and expenses to adhere to budget guidelines.
- Promoted safe work conditions by following safety procedures and reporting potential hazards.
- Participated in team-building activities to foster collaboration and communication.
- Supported a positive team environment by working with colleagues to complete tasks efficiently during peak hours.
- Streamlined back-of-house organization for easy access to supplies during shifts.
- Adapted to cross-training in multiple store roles to support coverage during absences and high-volume periods.
- Balanced multitasking and prioritization.
- Worked with team members during busy periods to maintain efficient workflow and limit wait times.
- Handled guest concerns promptly, leading to repeat business.
Education
Certificate Program - Advanced Drug Safety And Pharmacovigilance
MediPharm Solutions
Somerset, NJ02-2024
Certificate - Multimedia Program
I. T. Center
Gujarat, India08-2010
Diploma - I. T.
HARD-NET(Hardware And Networking Computer Institute)
Nagpur, India07-2008
Skills
- Pharmacovigilance tools: Argus and ArisG
- Coding standards: MedDRA & WHO Drug Dictionary
- ICSR handling & trial documentation
- Risk analysis
- Regulatory compliance: FDA & ICH guidelines
- Office suite skills: Word, Excel, Outlook
- Analytical thinking, problem-solving, teamwork, communication, time management, organization
Certification
Advanced Drug Safety and Pharmacovigilance Certification, 2023
Timeline
Drug Safety Specialist
MediPharmSolutions
08.2024 - 09.2025
Senior Sandwich Artist
Subway Restaurant
03.2015 - 11.2018
Certificate Program - Advanced Drug Safety And Pharmacovigilance
MediPharm Solutions
Certificate - Multimedia Program
I. T. Center
Diploma - I. T.
HARD-NET(Hardware And Networking Computer Institute)