Summary
Overview
Work History
Education
Skills
Driving Licence
Organisational Skills
Communication Skills
Personal Information
Training
Timeline
Generic
Madalina Manuela Bara

Madalina Manuela Bara

Bucharest

Summary

I am an enthusiastic pharmacist graduated in 2018 from Carol Davila University of Medicine and Pharmacy. Currently working as an Associate Site Manager and experienced also as pharmacist in the community pharmacy and Drug Safety Specialist. I am driven by my passion of learning new things every day and eager to contribute to team success through hard work. In my opinion the best way of growing is coming out of my comfort zone and facing new challenges. Hard work, team play and perseverance I think are the key to success. I am a very responsible and reliable person. I have learnt that it is important to be surrounded by people from whom you have a lot to learn. I am a very active person who enjoys going to the gym but also I like to read a good book. In my free time I like to spend some moments with my family and friends and doing things that stimulate my creativity.

Overview

10
10
years of professional experience
14
14
years of post-secondary education

Work History

Associate Site Manager

IQVIA
07.2023 - Current
  • Ensure adherence to good clinical practice (GCP), standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables, and to project timelines.
  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Review, prepare and negotiate site contracts and budgets with sites.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines.
  • Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory /ethics submissions and ICF adaptation and negotiation, in line with project timelines.
  • Provide local expertise to Clinical Operations Lead and Project team during initial and on-going project timelines planning.
  • Perform quality control of documents provided by sites.
  • Direct contact with sponsors on specific initiatives.
  • Perform Site Selection Visits.
  • Participate in feasibility and/or site identification activities.

Drug Safety Associate

Parexel International
07.2021 - 06.2023
  • Develop project specific safety procedure, workflows and templates
  • Setup of safety database (eg configuration to study's specifics), development of data entry guidelines if applicable
  • Case processing in safety database ARGUS including coding
  • Writing of case narratives
  • Request for follow-up and management of queries
  • Quality control
  • Monitor studies mailboxes
  • Participate in reconciliation of safety data (EDC versus ARGUS)
  • Create and maintain project specific working files
  • Maintain eTMF accuracy and on-time filing
  • Prepare for and participate in and follow up on audits and inspections

Pharmacovigilance Associate

PharmaCons PHVC
03.2020 - 06.2021
  • Data entry of all details readily available into safety database
  • Code adverse events in the safety database
  • Review and assess all required source documents, and accumulate data in an adverse event report
  • Execute labeling evaluation of adverse events
  • Assessing adverse event to adverse events formerly reported and listed in the product label
  • Reconciliation and follow up approach
  • Taking part in the development and maintenance of an efficient and robust Pharmacovigilance system

Pharmacist

Sensiblu SRL
06.2018 - 03.2020
  • Filling prescriptions and serving customers
  • Review and monitor medications and orders written by therapists and see if they are safe and effective
  • Prepare labels and dispenses medications for patients in accordance to the physicians' prescriptions and also follow the government regulations related to dispensing of drugs and narcotics
  • Maintain the required records of dispensing
  • Compound medications by following standard formulas and processes like weighing, measuring and mixing chemicals
  • Maintain the systems that charge or credit for medications
  • Answering queries and give information to customers on a drug, its side effects, dosage and storage
  • Follow the procedures of storage, quality assurance, security, and disposal of hazardous materials
  • Responsible for the activity of the pharmacy as a whole and represents it in front of the specialized organizations
  • Participates in the pharmacovigilance activity according to the legal stipulations

Medical sales representative

Totem Communication
03.2018 - 07.2018
  • Communicate with and persuade targeted doctors to prescribe our products utilizing effective selling skills and performing cost-benefit analysis
  • Building relationships with doctors
  • Assess clients needs and present suitable promoted products
  • Present product information and deliver product samples
  • Attend sales meetings, conference calls, training sessions and symposium circuits
  • Keep detailed records of all contacts
  • Work with sales team to develop strategies and implement brand strategies to ensure a consistent marketing message
  • Plan work schedules and weekly and monthly timetables with the area sales team or discuss future targets with the area sales manager

Internship

Dona Pharmacy
01.2018 - 06.2018
  • Quantitative and qualitative reception of medicinal products and medical devices
  • Storage of received products
  • Checking drug stocks and supplying shelves
  • Assist the pharmacist in filling prescriptions and serving customers
  • Follow the government regulations related to dispensing of drugs and narcotics
  • Maintain the systems that charge or credit for medications

Receptionist

Malakut Impex SRL
07.2016 - 08.2017
  • Performing daily administrative activities
  • Receiving visitors at the front desk by greeting, welcoming, directing and announcing them appropriately
  • Promoting to clients the activity, services, products and program of the gym
  • Primary accounting responsibilities, daily cash register
  • Receiving and sorting daily mail
  • Ensure reception area is tidy and presentable, with all necessary stationery and material
  • Provide basic and accurate information in-person and via phone/email
  • Order front office supplies and keep inventory of stock
  • Perform other clerical receptionist duties such as filing, photocopying, transcribing and faxing

Internship

Catena Pharmacy
07.2017 - 07.2017
  • Assist the pharmacist in filling prescriptions and serving customers
  • Follow the government regulations related to dispensing of drugs and narcotics
  • Maintain the systems that charge or credit for medications
  • Review and monitor medications and orders written by therapists and see if they are safe and effective

Internship

Catena Pharmacy
07.2016 - 07.2016
  • Quantitative and qualitative reception of medicinal products and medical devices
  • Storage of received products
  • Follow the procedures of storage, quality assurance, security, and disposal of hazardous materials
  • Maintain the required records of dispensing

Internship

HelpNet Pharmacy
07.2015 - 07.2015
  • Quantitative and qualitative reception of medicinal products and medical devices
  • Follow the procedures of storage, quality assurance, security, and disposal of hazardous materials
  • Maintain the required records of dispensing
  • Checking drug stocks and supplying shelves

Education

Laboratory tests Residency -

Emergency Clinical Hospital Bagdasar-Arseni
02.2023 - Current

Clinical Pharmacy Residency - undefined

Emergency Clinical Hospital "Dr. Bagdasar-Arseni"
02.2020 - 01.2023

Bachelor Degree - Pharmacy

Carol Davila University of Medicine and Pharmacy
Bucharest, Sector 2
10.2013 - 09.2018

High School Degree - undefined

IES Henri Matisse
09.2008 - 06.2012

Skills

Microsoft Office (Word, Excel, PowerPoint, Outlook)

Argus

Eudravigilance

CTMS

QArchive

undefined

Driving Licence

Yes, Yes

Organisational Skills

Being involved in different projects at the same time I had to develop my time management skills and make sure all my tasks were completed on time. I like to have everything scheduled every day. I have noticed that when I have everything written down I am more capable of doing more things during the day. Thanks to scheduling, my understanding of the time allocated to different aspects becomes improved. This helps me to keep control of different projects and tasks.

Communication Skills

The ability to work together as a team is extremely valuable for me. Team work involves many other interpersonal skills like communication, active listening, flexibility and responsibility. Those who are good team players are often given important tasks in the workplace and may be seen as the good candidates for promotions. For me communication is the key, if you want to succeed you need to develop your communication skills. It is important to know how to communicate with the others but also how to listen to other people's opinion. We can learn a lot if we know how to communicate properly. I have a very good vision of problems solving and also identifying business needs. Analytical skills include researching, problem solving, organization, creativity and theorizing, critical thinking and problem solving, fast learner and ability to work under pressure.

Personal Information

  • Date of Birth: 10/13/94
  • Gender: Female
  • Nationality: Romanian

Training

  • Evaluation of documentation for Clinical Studies, Carol Davila University of Medicine and Pharmacy, 03/01/18, 05/01/18, Building the basic principles needed to work in the field of clinical trials.
  • Regulatory Affairs Course by Ancuceanu Robert, Carol Davila University of Medicine and Pharmacy, 03/01/18, 05/01/18, Implementation of basic concepts in the field of pharmaceutical law.

Timeline

Associate Site Manager

IQVIA
07.2023 - Current

Laboratory tests Residency -

Emergency Clinical Hospital Bagdasar-Arseni
02.2023 - Current

Drug Safety Associate

Parexel International
07.2021 - 06.2023

Pharmacovigilance Associate

PharmaCons PHVC
03.2020 - 06.2021

Clinical Pharmacy Residency - undefined

Emergency Clinical Hospital "Dr. Bagdasar-Arseni"
02.2020 - 01.2023

Pharmacist

Sensiblu SRL
06.2018 - 03.2020

Medical sales representative

Totem Communication
03.2018 - 07.2018

Internship

Dona Pharmacy
01.2018 - 06.2018

Internship

Catena Pharmacy
07.2017 - 07.2017

Receptionist

Malakut Impex SRL
07.2016 - 08.2017

Internship

Catena Pharmacy
07.2016 - 07.2016

Internship

HelpNet Pharmacy
07.2015 - 07.2015

Bachelor Degree - Pharmacy

Carol Davila University of Medicine and Pharmacy
10.2013 - 09.2018

High School Degree - undefined

IES Henri Matisse
09.2008 - 06.2012
Madalina Manuela Bara