Seema Shah

Chart prepping, Chart screening, Patient recruitment, Patient Inform consenting, QA/QC, Data entry Shadowing Phase I-IV clinical trials

• Created and updated the patients’ profile with 100% accuracy in the Healthwatch system and transcribed prescription. • Efficiently resolved the insurance rejection, billing issues, patient inquiries about prescription filling and renewal process. • Performed and managed Inventory, narcotic count cycle, purchase order of medicines, audit preparation and training to new staff members timely manner.

Knowledge of Prescription Data entry, filling, cycle count, narcotics count, blister pack preparation medical Insurance compliance of the patient etc. Active participant of Covid vaccine clinic.

Hospital administrator and Pharmacist

• Designed analytical methods and validation protocols, drafting SOPs and the manuscripts of the scientific research and processed the publication of research papers as per Journal requirements. • Communicated with regulatory agencies on timely manner regarding submission requirements. • Identified and responded to issues related to assigned projects. • Accountable for a portfolio of client products, including the preparation, CMC filing details and approval of regulatory submissions as per USFDA, CDSCO. • Worked effectively in collaboration with other members of the departments. • Prepared and documented for the internal audit, client visit or regulatory audit as timely manner.

• Working efficiently in Pharmaceutical Analysis and Quality Assurance and Regulatory Affairs department for B.Pharm and M. Pharm students • Guided students regarding quality assurance and regulatory submission guidelines USFDA-NDA, HC-NDS, IND, ICH, GCP, GLP, cGMP, ANDS, MHRA and its applications of pharmaceutical products and medical devices in Regulatory field. • Directed the postgraduate students for industry projects and research paper writing process and actively worked for internal committees like Examination, Regulatory agency -AICTE and GTU.

• Performed and maintained the in-process quality control of each stage of manufacturing process, annual MVP (Master Validation Plan) and MCP (Master Calibration Plan) of Fluid Therapy, Medical devices and NOVA division which are worked as per the norms of cGMP and USFDA. • Accomplished all the validation processes and maintained internal and external regulatory documentation database, updated change control processes. • Prepared Regulatory Working Instructions/Flow Processes/Procedures, as required. • Ensured all work is in compliance with applicable company standard, ISO standards, GLP, GMP and established SOPs. • Researched regulatory issues and dispersed regulatory information to Production, QA/QC departments. • Assisted with regulatory compliance activities such as labelling reviews, post-market reports of parenteral and medical device products.

• Performed recruiting and screening process of participants for respective trial. • Maintained the source documents, employee personal records, training records, administrative logs and trackers according to ALCOA (Attributable, legible, contemporaneous, original and accurate). • Administered investigational products, extracted and transcribed source data to CRFs. • Designed and implemented tools like database, spreadsheet, log sheet to monitor and record daily basis administrative and clinical trial activities. • Ensured updated Informed Consent Forms, protocol, SOPs for clinical trial study used and all documents compliance with ICH-GCP. • Communicated with staff members through meeting and training about Team project.

List of Projects performed during academic year: 1. CLINICAL STUDY: FDA AUDIT PREPARATION-Review article 2. Labelling Requirement of Medical Devices as per Health Canada by selecting class 2 and 3 products 3. Development of Protocol and Informed Consent form for the clinical trial study - EMPA post-GDM 4. Design the Benefit- Risk Assessment of Empagliflozin 5. Drug Product labelling as per USFDA, EMA and HC 6. Preparation of the Pre-NDS meeting with Health Canada- Request for Priority Review of New Drug Submission 7. Common Technical Document (eCTD) management-Module 2.6 8. Finding Discrepancies in ICF with respect to Investigational Medicinal Product and Protocol of the Droxidopa in clinical trial study 9. Development of Gantt chart for Clinical trial project management (using hypothetical clinical trial flow chart) 10. Presentation of the Pharmaceutical company- AbbVie updated clinical research pipeline (from Phase 1 to registration) and related information with safety summary

Shree S. K. Patel Institute of Pharmaceutical Education and Research, Kherva, Gujarat

National College of Pharmacy, Shimoga

L.M. College of Pharmacy, Ahmedabad