Deputy QPPV and Regulatory Affairs Specialist
Resume:
Mouna CHAKROUN
Doctor of Philosophy (Ph.D.) in Biological Sciences
Expertise in pharmacovigilance and regulatory affairs Cité les Palmerais l’Aouina
*************@*****.***
● PROFESSIONAL EXPERIENCE
SAIPH Group, Tunis — Export Regulatory affairs specialist and deputy QPPV
June 2022- till now
Export Regulatory affairs Specialist:
• Conduct registration document compilation and submission for all products to be registered in designated countries (IRAQ, JORDAN, ALGERIA, IVORY COAST)
• Develop and implement regulatory strategies for products in line with international regulations and guidelines.
• Manage and Create all Export certificates (CPPs &FSC), Composition sheets, Declaration letters and registration related documents requested.
• Manage CTD dossiers for the requested products.
• Create regulatory standard operating procedure as necessary for each country: coordination with the research teams, medical, marketing & quality departments.
• Handle all artwork related requirements for export; Prepare & Revise all ingredient lists with (English, French & Arabic languages).
Deputy QPPV:
• Assist the QPPV Pharmacovigilance Manager in implementing and maintaining a robust pharmacovigilance system.
• Develop and maintain pharmacovigilance documentation: PSMF & SOP
• Conduct pharmacovigilance audits and inspections.
• Internal audit coordination, reply & follow up.
• External Audit coordination with auditors and complete the audit process.
• Ensuring and maintaining the effective development of Corrective and Preventive Actions (CAPA)
• Review and analyze individual case safety reports (ICSRs)
• Monitor key performance indicators (KPIs) for pharmacovigilance activities
• Identify and analyze performance gaps in the pharmacovigilance system
• Prepare and deliver performance reports to stakeholders
• Drafting and reviewing RMP and PSUR reports
• Perform reconciliation with business partners for AE report exchanges.
• Perform intake, follow-up and data review of adverse event (AE) cases.
• Participating in pharmacovigilance conferences
• Assist in developing and conducting AE reporting training for Sales Force
• Stay up to date on the latest developments in pharmacovigilance regulations and
SKILLS
Well Organized, sense of
responsibility
Flexible mindset
Attention to detail
Strong knowledge of
appropriate software (e.g.,
Windows File Management, Adobe
InDesign, Microsoft Word, Excel,
PowerPoint, QUALI PRO, SAGEX3)
Work ethic
Time management
DISTINCTIONS
Recipient of a research
grant from the European Union
(EU) for an innovative project
in Cell Biology in 2019
9 Scientific articles
published
LANGUAGE
English: Upper Intermediate B1
French: Upper Intermediate B2
Arabic: Native level
best practices
SAIPH Group, Tunis — Export Regulatory affairs officer August 2021- May 2022
-Preparation, Registration and Follow-up of foreign drug dossiers: study of technical and regulatory requirements, implementation of the regulatory strategy according to the requirements of each country.
-Preparation of CPPs, GMP, Certificates of Analysis PF (finished product) and SA (active substance).
-Elaboration, validation and diffusion of texts related to packaging articles and product information (RCP, ARTWORKS).
Boudjebel VACPA, Nabeul — Postdoctoral Researcher
January 2019-Feb 2021
Collaboration with VACPA industry and PAB (Physiopathology, Alimentation and Biomolecules, PAB, laboratory) of the Higher Institute of Biotechnology Sidi Thabet (ISBST).
● TRAINING
National center of pharmacovigilance CNPV, Tunis
Bioequivalence study
June 2024
One Step Institude, Tunis - Management of stability studies May 2024
Ben Hamouda Consulting, Tunis - MINI PMP
April 2024
SMF Life Science, Tunis -Regulatory Affairs Workshop April 2024
NGstudy, Tunis - Negotiation Associate
March 2024
Scrum Fundamentals Certified (SFC™), Tunis - Scrum Fundamentals Certification
March 2024
Scrumstudy, Tunis -Scrum for Ops and Dev Ops Fundamentals Certified
March 2024
6sigmastudy, Tunis - Six Sigma Yellow Belt
March 2024
CI - Language & Culture Institute, Tunis - Business communication January 2024
SMU - South Mediterranean University (MSB- MedTech-LCI), Tunis- Business English B.1.1
October 2023
National center of pharmacovigilance CNPV, Tunis
Implementation of a Pharmacovigilance System
June 2023
● CONGRESS
The first National Pharmacology Congress, October 19-20-21, 2023, Hammamet
● PROJECTS
Mobidoc Postdoctoral Researcher: Developing and exploiting the anti-tumor activity of bioactive biomolecules derived from date stone powder. 2019-2021
Collaboration with VACPA industry and PAB (Physiopathology, Alimentation and Biomolecules, PAB, laboratory) of the Higher Institute of Biotechnology Sidi Thabet (ISBST).
Contact this candidate