Elizca Pretorius
Sandton
Summary
A registered Pharmacist with experience in Retail, Distribution, Quality Assurance, Regulatory Affairs and Pharmacovigilance. Regulatory Affairs skills was mastered during the SAHPRA backlog project as part of a 2 person team that submitted over 40 dossiers without missing a deadline. Passed a SAHPRA inspection of the Quality Asssurance systems and maintained a local Pharmacovigilance system according to SAHPRA requirements.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Deputy Responsible Pharmacist
Glenmark Pharmaceuticals South Africa (Pty) Ltd
Edenvale
10.2019 - Current
Quality Assurance
- Ensure that all the quality assurance/ GMP requirements are met
- Conducting external third-party audits
Local Responsible Person for Pharmacovigilance
- Maintain a pharmacovigilance system in accordance with SAHPRA requirements and those of the Glenmark pharmacovigilance unit
Regulatory Affairs
- Reviewing, evaluating and endorsing all of the technical documents in accordance with the requirements of the relevant registration and ensuring compliance with applicable submission requirements
- Registration of all products in accordance with the requirements of the regulatory authority (RA)
- Submission of post registration amendments as soon as registration is finalised in accordance with the requirements of the RA in SA and Glenmark standards
- To ensure company compliance with regulatory requirements relating to the submission and maintenance of medicines in South Africa and other designated territories
Deputy Responsible Pharmacist
Aurogen South Africa (Pty) Ltd
Meyersdal
11.2018 - 09.2019
Quality Assurance
- Ensure that all the quality assurance/ GMP requirements are met
- Conducting external third-party audits
Local Responsible Person for Pharmacovigilance
- Maintain a pharmacovigilance system in accordance with SAHPRA requirements and those of the Glenmark pharmacovigilance unit
Regulatory Affairs
- Reviewing, evaluating and endorsing all of the technical documents in accordance with the requirements of the relevant registration and ensuring compliance with applicable submission requirements
- Registration of all products in accordance with the requirements of the regulatory authority (RA)
- Submission of post registration amendments as soon as registration is finalised in accordance with the requirements of the RA in SA and Glenmark standards
- To ensure company compliance with regulatory requirements relating to the submission and maintenance of medicines in South Africa and other designated territories
Method Transfer QA Pharmacist
Sandoz South Africa (Pty) Ltd
Kempton Park
03.2018 - 10.2018
- Coordination for the imported quality stream products' method transfer (MT) project
- Transfer of analytical methods for Sandoz imported bulk from the Sandoz Spartan Laboratory to suitable external commercial laboratories
- Assist in Product Quality Review
- Quality Assurance review of Marketing Artwork
Locum pharmacist
Various
Gauteng
02.2017 - 02.2018
- Counseled patients regarding proper intake of medications.
- Read, Evaluate and Dispense prescriptions to patients
- Provided consultations and answered inquiries from patients, healthcare professionals and physicians regarding medicines, potential side effects and specified use.
Education
Master of Science - Pharmaceutics
North West University
Potchefstroom, South Africa2015
Bachelor of Pharmacy -
North West University
Potchefstroom South Africa2013
Bachelor of Science - Physiology and Psychology
University of Johannesburg
Johannesburg, South Africa2008
Grade 12 (Cambridge) -
Leeuwenhof Akademie
Bedfordview, South Africa2005
Skills
- Computer Skills - Microsoft Office
- Analytical and Critical Thinking
- Multitasking Abilities
- Self-Motivated
- Responsible and reliable
Accomplishments
- Part of a team of two Pharmacists that completed over 40 dossiers in 14 months during the SAHPRA backlog project
- Documented and resolved Product quality complaints, Adverse drug reactions and Medical Information enquiries which led to a significant shortening of turn around times.
Affiliations
South African Pharmacy Council
Pharmaceutical Society of South Africa
Certification
2017 - Medicines Registrations (Basic Course) - QuadPharma
2017 - Training Workshop on Regulatory Writing – Focusing on Writing CTD’s for Complementary Medicines - SMASA, MRA
2019 - Marketing Code Authority (MCA) Training - MCA
2019 - Hands-on Training: Compilation of Modules 2 (P&A) and 3 of CTD - SAAPI
2020 - Pharmacovigilance in a changing world - PharmaTraining
Languages
English
Bilingual or Proficient (C2)
Afrikaans
Bilingual or Proficient (C2)
Timeline
Deputy Responsible Pharmacist
Glenmark Pharmaceuticals South Africa (Pty) Ltd
10.2019 - Current
Deputy Responsible Pharmacist
Aurogen South Africa (Pty) Ltd
11.2018 - 09.2019
Method Transfer QA Pharmacist
Sandoz South Africa (Pty) Ltd
03.2018 - 10.2018
Locum pharmacist
Various
02.2017 - 02.2018
Master of Science - Pharmaceutics
North West University
Bachelor of Pharmacy -
North West University
Bachelor of Science - Physiology and Psychology
University of Johannesburg
Grade 12 (Cambridge) -
Leeuwenhof Akademie