Bhagyashree Inamdar (Shree) Email & Phone Number

Mumbai, Mh, In

Mississauga, Ontario, Canada

• Process prescription orders by accurately entering information into the pharmacy management system (Rx Connect and Kroll).• Verify prescription details, patient information, and insurance coverage to ensure accuracy and completeness.• Communicate with healthcare providers and team members to clarify and resolve prescription issues.• Maintain up-to-date records and ensure timely processing of prescription orders.• Prioritize tasks to maintain workflow efficiency in a fast-paced environment.• Support inventory management and adhere to pharmacy regulations and guidelines.

Mississauga, Ontario, Canada

•Dispensed prescription and over-the-counter medications accurately while managing inventory using Filware pharmacy management software.•Handled customer interactions professionally, including phone inquiries and in-person consultations.•Assisted in preparing compounded specialty medications, developing compounding procedures, creating risk assessments, and developing master formula records.•Supported patients undergoing treatment for substance abuse and managed the proper storage and transportation of biological samples.•Assembled compliance packs, organizing and labeling medications in blister packs with photos and dosage times to help patients manage multiple prescriptions effectively.

Navi Mumbai, Maharashtra, India

Led Moderately Sized Cardiovascular Study (Start-up Lead & SME):Reduced regulatory approval by 50% (3 months) compared to prior studies.Achieved a 10% reduction in overall start-up timeline.Improved patient recruitment efficiency by 10% through supply management.Key Responsibilities:Managed site activation, study operations, and regulatory submissions.Streamlined study approval with regulatory authorities.Optimized TMF processes and documentation.Mentored CRAs on project documentation collection.Ensured up-to-date and accessible study documentation.Secured import licenses within 2 weeks, demonstrating regulatory expertise.

India

Managed Local Regulatory Submissions and Strategy:Prepared, reviewed, and coordinated submissions (MoH, EC, etc.) for global clinical trials.Advised internal clients on local regulatory strategy (MoH &/or EC).Served as key regulatory contact for MoH/EC submissions at the country level.Ensured site start-up activities aligned with submission timelines, accelerating site activation.Additional Responsibilities:Developed country-specific patient information sheets and informed consent forms.Maintained accurate trial status information in PPD tracking databases.Ensured compliance with PPD WPDs and client SOPs for local country study files

Thane, Maharashtra, India

Acts as In-House CRA Performs and Coordinates all aspects of the clinical monitoring in accordance with ICH GCP, FDA guidelines, local regulations and Clinical Operating Procedures Assist the CRAs with the preparation of information Site Packs consisting of detailed site data prerequisite for site visits Participation weekly site follow-ups, CRA follow ups and project leadership calls Provides trial status tracking and progress update reports to the Clinical Lead and Project Lead Any other monitoring activities assigned as per the project requirement Working with different stakeholders within the organisation

Thane, Maharashtra, India

Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelinesEstablish and maintain effective project/ site communicationsCreate and maintain relevant project documentsEnsure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific informationParticipate in document management (creation, review, maintenance, storage, as applicable

Bachelor Of Pharmacy

Master Of Pharmacy, Quality Assurance, Outstanding