Post-Market Surveillance and Vigilance Manager (SaMD)

• Apr 2022 - Present

- Responsible for implementing (EU) 2017/745 (MDR) in the areas of Software as Medical Device (SaMD), Medical Device Safety, PMS and vigilance. - Managing recurring user & patient safety-related activities, including review and analysis of post-market surveillance feedback to identify areas of continuous improvement.- Responsible for complaint identification, escalation, investigation, and resolution.- Responsible for SOP and WOI writing, updating, organizing trainings, and maintenance in QMS.- Supporting the compilation of relevant safety data reports, including PMSRs, PSURs, and others as per regulatory requirements and providing expert opinion.- Collaborating productively on medical safety tasks with stakeholders from Clinical Evaluation, Regulatory Affairs, Medical Product, and other related departments.- Supporting the trend analysis of complaint and feedback data for products, contributing to the early identification of safety-related signals- Contributing to risk assessment processes, providing input based on your understanding of post-market surveillance data- Screening relevant scientific literature and regulatory databases to identify and retrieve safety information about Ada’s products and similar devices on market. Show less

User/Patient Safety Specialist

• May 2021 - Apr 2022

- Managing recurring user & patient safety-related activities, including review and analysis of post market surveillance feedback to identify areas of continuous improvement.- Contributing to complaint identification, escalation, investigation and resolution.- Supporting the compilation of relevant safety data reports, including PMSRs, PSURs and others as per regulatory requirements.- Performing trend analysis of complaint and feedback data for products, thereby contributing to the early identification of safety-related signals.- Contributing to risk assessment processes and providing input based on post-market surveillance data.- Screening relevant scientific literature and regulatory databases to identify and retrieve safety information about Ada's products and similar devices on market. Show less

Pharmaceutical Specialist

• Aug 2020 - Aug 2020

DendroPharm is a pharmaceutical company that uses nanotechnology to develop NanoCarriers to deliver the drug to the target, thereby modulating the pathway of drugs and creating safer and more efficient alternatives. During my internship, I was responsible for developing transdermal formulations to facilitate the administration and penetration of antidepressant drugs through the skin. Moreover, nanocarriers were included in these formulations to test whether or not they enhance the penetration of the active ingredients. To evaluate the in-vitro drug permeation, experiments on several skin types were carried out using Franz Diffusion Cells. Analysis of plasma concentrations were performed using HPLC. Show less

Graduate Teaching Assistant

• Feb 2018 - Jun 2018

Within the FUE's Department of Pharmacy Practice and Clinical Pharmacy, I worked as a graduate TA where I: • Provided assistance to faculty members or staff with laboratory research or projects. • Lead discussion sections, tutorials, or laboratory work. • Evaluated and graded exams, assignments, and recorded grades. • Attended training sessions and meetings to develop and maintain my professional knowledge. Within the FUE's Department of Pharmacy Practice and Clinical Pharmacy, I worked as a graduate TA where I: • Provided assistance to faculty members or staff with laboratory research or projects. • Lead discussion sections, tutorials, or laboratory work. • Evaluated and graded exams, assignments, and recorded grades. • Attended training sessions and meetings to develop and maintain my professional knowledge.

Pharmacist

• Jun 2017 - Dec 2017

- Responsible for dispensing OTC and prescription medications. - Patient counseling. - Responsible for dispensing OTC and prescription medications. - Patient counseling.

Clinical Pharmacist Intern

• Aug 2016 - Aug 2016

Medical Representative Intern

• Aug 2014 - Oct 2014

on Symbicort Inhaler. on Symbicort Inhaler.