Experience

CROMSOURCE - A ClinChoice Company

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Project Coordinator

  • Jan 2023 - Present

  Performs administrative in house management of clinical trials which includes setting up, collecting and filing essential clinical trials documentation (TMF) and correspondence in order to assist the PMs/CRAs in managing the clinical trial. Ensures high quality and up to date information in planning and tracking tools for project and study level data (eTrack, centralised lab exams, drug shipments, documents shipment etc). Collaborates with the CTA/CRA in terms of local authorities approval… Show more Performs administrative in house management of clinical trials which includes setting up, collecting and filing essential clinical trials documentation (TMF) and correspondence in order to assist the PMs/CRAs in managing the clinical trial. Ensures high quality and up to date information in planning and tracking tools for project and study level data (eTrack, centralised lab exams, drug shipments, documents shipment etc). Collaborates with the CTA/CRA in terms of local authorities approval activities. Ensures the study documents are appropriately filed in eTMF and perform QC. Manages the correct development of the clinical project, interacting with the Investigators under the supervision of PM/SPM. Keeps herself professionally abreast if all scientific, regulatory and operational aspects relevant to the clinical projects she will be assigned. Should be knowledgeable, following appropriate trainings, in the application and/or dispatch of study material supplies to guarantee timely provision of study sites. Assures the proper timelines of the assigned tasks. Supports CRAs/CMs with site management and remote monitoring activities. Collaborates with CTAs in archiving activities. Supports in organising Monitor’s and Investigator’s meetings. Follows up with study team members as needed and escalates any issue to PMs. Takes part and provides support to the PMs in coordination of project and study relevant meetings. Informs PM/SPN about any issues. May act as Feasibility Associate after appropriate and documented training. Provides general administrative support for the Clinical Research Operations department allowing for successful completion of its operations. Collaborates in complying and enforcing company procedures.

• Global Pharmacovigilance Technology Specialist

  • Sep 2022 - Jan 2023

  act as Safety Database administrator (“PV administrator”), act as a reference point of contact for the IT Service Providers, represent GPV on the basis of the knowledge of the business processes and procedures, assess technology requirements and new needs to prioritize them and conceive evolutionary strategies for the service, in collaboration with Global Information and Communications Technology (GICT) business partner, plan the implementation of IT solutions in the pharmacovigilance field… Show more act as Safety Database administrator (“PV administrator”), act as a reference point of contact for the IT Service Providers, represent GPV on the basis of the knowledge of the business processes and procedures, assess technology requirements and new needs to prioritize them and conceive evolutionary strategies for the service, in collaboration with Global Information and Communications Technology (GICT) business partner, plan the implementation of IT solutions in the pharmacovigilance field, ,manage technicalities of corporate portals and gateways for cases’ e-submissions, (e.g. rejections and system reporting rules), supervise the verification of local reporting rules for further validation and corresponding updates to the systems, assist PV Users (first point of contact) and PV Service Providers in the ordinary use of the service, evaluate skills and organize the necessary training activities in collaboration with the line manager, develop and maintains Standard Operating Procedures and Working Instructions in the field and administer concerned training, open deviations related to the activities under the role and contribute to the investigation(s) and CAPA plan implementation.



ProPharma

• United States
• Business Consulting and Services
• 700 & Above Employee

• Senior Pharmacovigilance Specialist

  • May 2021 - Jul 2022

  Italy Case and event assessment Identify events and code using MedDRA Determine seriousness and expectedness of each event. Determine overall case assessment of seriousness and expectedness. Perform assessment review, capture causality Case follow-up activities Identify information to be collected during follow-up Conduct follow-up calls and prepare written communications to obtain follow-up information MedWatch, CIOMS, E2B Preparation Conduct daily review of medical… Show more Case and event assessment Identify events and code using MedDRA Determine seriousness and expectedness of each event. Determine overall case assessment of seriousness and expectedness. Perform assessment review, capture causality Case follow-up activities Identify information to be collected during follow-up Conduct follow-up calls and prepare written communications to obtain follow-up information MedWatch, CIOMS, E2B Preparation Conduct daily review of medical information cases Write case narratives and review MedWatch/CIOMS/E2B forms Provide signal detection analysis within aggregate reports Perform in-line case QC review including the following, but not limited to: Report Type/Reportability Event MedDRA coding Seriousness and expectedness at the event and case level Accuracy and completeness of the narrative Provide feedback for development of training material Creation of training materials on different topics of interest Team trainer on processing cases on Argus Line manager duties Report submission procedure Conduct investigations for Deviations and CAPA and write reports Show less



Farmacia Mannucci Dr Francesco

• Pharmacist

  • Jan 2021 - Mar 2021

  Falconara Marittima, Marche, Italia Description: providing drugs both with prescription and OTC, cosmetics and beauty products seller, check of blood pressure and glucose blood level. Learned Skills: · to adapt to a new products, environment, rules and policies · to understand the new policies about drugs, safety and administration due to the COVID pandemic and act upon them · to answer patients questions about their medications such as posology, interactions, eventual allergies and length of the treatment and provide… Show more Description: providing drugs both with prescription and OTC, cosmetics and beauty products seller, check of blood pressure and glucose blood level. Learned Skills: · to adapt to a new products, environment, rules and policies · to understand the new policies about drugs, safety and administration due to the COVID pandemic and act upon them · to answer patients questions about their medications such as posology, interactions, eventual allergies and length of the treatment and provide new acute treatments required Show less



Royal Free Hospital NHS Foundation Trust, Outpatient Pharmacy, ICDC Pharmacy

• Pharmacy Technician

  • Oct 2019 - Nov 2020

  Hampstead, London, UK Description: Dispensing medications, administrative duties including answering the phone, handing out medications to patients, checking the daily stock, daily refilling of the robot system. Learned Skills: • to be extremely accurate and as quick as possible on checking patient details, posology, quantity and interactions • to solve queries regarding patients, prescriptions and requests from other hospital departments • to answer patients questions about their medications such as… Show more Description: Dispensing medications, administrative duties including answering the phone, handing out medications to patients, checking the daily stock, daily refilling of the robot system. Learned Skills: • to be extremely accurate and as quick as possible on checking patient details, posology, quantity and interactions • to solve queries regarding patients, prescriptions and requests from other hospital departments • to answer patients questions about their medications such as posology, interactions, eventual allergy and lenght of the treatment • to improve my mathematical skills by double checking the doses and quantities • to dispense any CD prescriptions with the right procedure • to work in a large team Show less



Coopers Chemist

• Pharmacy Dispenser

  • Oct 2018 - Oct 2019

  Willesden Green NW10 2PB, London, UK Description: Processing prescriptions and labeling, collecting medications to dispense, Dosette Boxes maker, request medications for patients, checking and renewing the daily orders from various suppliers. Computer program used: ProScript Connect. Learned Skills: • to clinically check patients’ records • to check if dose or posology prescribed are right for the patient • to speak and deal with prescribers, also on the phone, and to solve current issues • to speak directly with… Show more Description: Processing prescriptions and labeling, collecting medications to dispense, Dosette Boxes maker, request medications for patients, checking and renewing the daily orders from various suppliers. Computer program used: ProScript Connect. Learned Skills: • to clinically check patients’ records • to check if dose or posology prescribed are right for the patient • to speak and deal with prescribers, also on the phone, and to solve current issues • to speak directly with the patients and explain the posology of medications • to order special items on the phone • to work under pressure and in a rush and doing various tasks at the same time • to work in a large team • knowledge about SOP • NMS and MUR procedures and to talk to patients in the most comprehensible way Show less



Farmacia Capponi

• Pharmacist

  • Nov 2017 - Jul 2018

  Camerata Picena, Ancona, Italy Description: Drug seller, administrative tasks, drug daily orders, making of galenical products, cosmetic and beauty products seller and medication advisor. Learned Skills: · to pass my knowledge in an easy and comprehensible way · to work under pressure and to be kind to everyone · to be organized and accurate