Souhila TADJER
Regulatory Affairs Specialist | Pharmacovigilance
Salaire / Taux journalier
Alger, Algérie
Freelance, ouvert au CDI
À propos
Introduction
Regulatory Affairs & Market Access specialist with 3+ years expertise in pharmaceutical registration, lifecycle management, and compliance across Algeria's healthcare landscape. Proven track record managing product registrations, reimbursement processes, pharmacovigilance, and QMS implementation while liaising with MOH, ANPP, and regulatory authorities. Deliver end-to-end regulatory solutions ensuring timely market access and compliance for pharmaceutical products.
Expérience de travail
Regulatory affairs specialist/ pharmacist assistant of the PDT
Abdi Ibrahim Remede Pharma - AIRP
sept. 2023 - Présent
3 ans 2 mois
Kouba, Algérie
- Represent the company & work closely with competent health authorities – MOH, ANPP, ministry of labor & LNCPP - Responsible , for allocated products, of registration and life cycle management activities (Local production and Importation); by insuring timely preparation and submission of new registration, renewal and variation application to the local authorities and ensure appropriate followup with external and internal stockholders. - Ensure permanent compliance to local regulatory requirements, policies and procedures. - Provide impact assessment of new and updated regulations/requirements and ensure effective communication internally. - Ensure product release (Local production and Importation) as per the sales schedule. - Ensure Request and granting of import permits. - Plan, undertake and oversee regulatory inspections & parteners audits. - Contribute to Pharmacoeconomics studies with medical & marketing departments. - Handle the preparation, submission and follow up of reimbursement requests to the CRM. - Handle the price increases requests. - Responsible for Implementing and maintaining a Quality Management System to ensure that GDP, GMP and local regulatory requirements are met in particular : * Ensure that all SOPs are in place and in use. *Ensuring that initial and continuous training programs are implemented and maintained. *Change control process management including Change control assessment and regular followup until their closure. *Coordinating and promptly performing any recall operations for medicinal products ; *Ensuring that relevant customer complaints are dealt with effectively; *Deciding on the final disposition of returned, rejected, recalled or falsified products; - Monthly and weekly Stock declaration to MIPP
AlphaRep Pharma
sept. 2021 - août 2023
2 ans
Chéraga, Algérie
Pharmacist assistant /Regulatory affairs and pharmacovigilance pharmacist.
avr. 2022 - août 2023
1 an 5 mois
Chéraga, Algérie
- Represent the company & work closely with competent health authorities – MOH, ANPP, LNCPP & CNPM. - Responsible of pharmacovigilance: declaration of CIOMS and submission of PSURs to the CNPM, declaration of local ADRs. - Keeping up-to-date changes in regulatory legislation & Guidelines. - Ensure interim of technical director exploitant during his absence. - Preparing, auditing, submitting & following up registration, variation and renewal dossiers for pharmaceuticals products. - Following pricing committees & price negotiation with MIPP. - Declaration of scientific events participation & sponsorship to the MoPI. - Obtaining advertising visas for all promotional materials - Reviewing and validating promotional material. - Reviewing and validating the packaging items. - Preparation and submission of import permit for registration samples. - Prepare and submit payment slips for registration and promotion fees.
Regulatory affairs and pharmacovigilance pharmacist
sept. 2021 - mai 2022
9 mois
Chéraga, Algérie
- Represent the company & work closely with competent health authorities – MOH, ANPP, LNCPP & CNPM. - Responsible of pharmacovigilance: declaration of CIOMS and submission of PSURs to the CNPM, declaration of local ADRs. - Keeping up-to-date changes in regulatory legislation & Guidelines. - Preparing, auditing, submitting & following up registration, variation and renewal dossiers for pharmaceuticals products. - Following pricing committees & price negotiation with MIPP. - Declaration of scientific events participation & sponsorship to the MoPI. - Obtaining advertising visas for all promotional materials - Reviewing and validating promotional material. - Reviewing and validating the packaging items. - Preparation and submission of import permit for registration samples. - Prepare and submit payment slips for registration and promotion fees.
Pharmacy Assistant
Cheraga drugstore
oct. 2018 - août 2023
4 ans 11 mois
Kouba, Algérie
- Dispensing medications, - Advising on medication use, - Stock management.
Trainee pharmacist
National Agency of pharmaceutical products( ANPP)
avr. 2021 - août 2021
5 mois
Chéraga, Algérie
- Reception & Evaluation of registration, variation and renewal dossiers for pharmaceuticals products (imported &local manufactured product). - Responsible of the feasibility study regarding the quality control of the imported product.
Trainee pharmacist
Direction des activités pharmaceutique et de la regulation/ ministère de l'industrie pharmaceutique
janv. 2021 - mars 2021
3 mois
Chéraga, Algérie
- Reception & evaluation of import permits and regulation certificate.
Pharmacy Intern
CHU Béni Messous
sept. 2019 - oct. 2020
1 an 2 mois
Alger, Algérie
Trainee
Pharmalliance
déc. 2019 - janv. 2020
2 mois
Alger, Algérie
- Training on the Research and development laboratory -Department of Regulatory Affairs.
Formation
Algiers Faculty of Medicine
Doctor of Pharmacy - PharmD,
2014 - 2020
7 ans
Hopeland Institut
English Language
2018 - 2019
2 ans