Sylvia Makena
Regulatory Compliance Pharmacist
Summary
A detail-oriented and results-driven professional with a strong commitment to excellence, seeking a challenging role as Regulatory Affairs Pharmacist. I demonstrate a proven ability to rapidly assimilate new information, adapt to diverse environments, and maintain a high level of productivity. With a solid foundation in self-motivation, effective teamwork, and a strong sense of accountability, I consistently contribute to organizational success while upholding the highest standards of compliance and ethical practices.
Overview
5
5
years of professional experience
1
1
Language
Work History
Regulatory Compliance Pharmacist
ADCOCK INGRAM
10.2023 - Current
- Creating Professional Information (PI) and Patient Information Leaflets (PILs) for new IP.
- Ensuring accurate uploading of the current approved PIs and PILs to the SA Regulatory Portal and submission to SAHPRA for uploading to the PI/PIL Repository.
- Managing of foodstuffs, Cosmetic and Medical devices.
- Accurate compilation and filling of the electronic submission documentation.
- Evaluating all artwork elements (PI / PIL / Foil l / Carton) and ensuring compliance with guidelines.
- Participating in cross-functional team meetings to discuss and resolve issues surrounding controversial material.
- Interpreting the regulations and the guidelines and facilitating implementation on an operational level.
- Participating in internal self-inspections and audits as appropriate.
- Compiling statistics and reports for business updates.
- Author, updating and maintaining SOPs for the Compliance department, and ensuring effective implementation of SOPs.
- Providing training to company staff to ensure compliance of aa employees with the laws and codes of the industry as well as competence and compliance with internal policies and SOPs.
Pharmacist
BRITS DISTRICT HOSPITAL
01.2022 - 12.2022
- Stock control and waste management.
- Maintaining accurate and appropriate records in line with legal requirements.
- Participating Antibiotic Stewardship program.
- Providing expert advice to medical staff on effective and economic usage of drugs.
- Review prescriptions daily and implement.
- Providing pharmaceutical care to patients and ensuring rational drug use is taking place.
Pharmacist intern
DISCHEM PHARMACIES
01.2021 - 12.2021
- Stock control and waste management.
- Dispensing medications on the prescription of a person authorised to prescribe medicine.
- Compounding, manipulation, preparation and packaging of medication.
- Counselling patients on the rational use of medicines.
- Patient initiating therapy.
- Promoting health and awareness to the community.
Education
Bachelor of Pharmacy -
Tshwane University of Technology
01.2017 - 12 2020
National Diploma in Analytical Chemistry - undefined
Tshwane University of Technology
01.2014 - 7 2017
Skills
- Computer Literacy
- Organizing and planning skills
- Time management skills
- Decision making skills
- Interpersonal skills
- Written communication skills
- Verbal communication skills
- Problem solving
- Analytical skills
- Regulatory compliance
- Medication dispensing and immunizing
- Drug safety
- Drug inventory management
- Staff training
- Regulatory requirements
Work Style
- Language Proficiency: Knowledge of the structure and grammar of the English Language.
- Attention to Details: Careful about detail and thorough in completing work tasks.
- Motivation: Highly motivated.
- Adaptability: Open to change and to considerable variety in the workplace.
- Stress tolerance: Accept criticism and deal calmly and effectively with high stress situations.
- Integrity: Honest and ethical.
- Dependability: Reliable, responsible and dependable, fulfilling obligations.
- Leadership: Willingness to lead, take charge and offer opinions and direction.
Personal Information
- ID Number: 9505310643084
- Nationality: South African
- Driving License: Code C1(2019)
Additional Information
- Regulatory Authority requirements
- Medical information requirements and information management
- The laws and requirements governing the marketing of medicines and printed packaging guidelines and codes of practice
- DocBridge and DrugTrack and eCTD format.
REFERENCES
Available upon request
Timeline
Regulatory Compliance Pharmacist
ADCOCK INGRAM
10.2023 - Current
Pharmacist
BRITS DISTRICT HOSPITAL
01.2022 - 12.2022
Pharmacist intern
DISCHEM PHARMACIES
01.2021 - 12.2021
Bachelor of Pharmacy -
Tshwane University of Technology
01.2017 - 12 2020
National Diploma in Analytical Chemistry - undefined
Tshwane University of Technology
01.2014 - 7 2017
Similar Profiles
ZAKIYA SORAGEE-SHOZIZAKIYA SORAGEE-SHOZI
Territory Sales Manager at Adcock IngramTerritory Sales Manager at Adcock Ingram
Themba Gift MngomezuluThemba Gift Mngomezulu
Sterile Operator at Adcock IngramSterile Operator at Adcock Ingram
Polotso SehlaboPolotso Sehlabo
Compliance Laboratory Analyst at Adcock IngramCompliance Laboratory Analyst at Adcock Ingram
Nicholas NgNicholas Ng
Regulatory Compliance Pharmacist at Bright Future Pharmaceutical FactoryRegulatory Compliance Pharmacist at Bright Future Pharmaceutical Factory
Nonhle ZwaneNonhle Zwane
Regulatory Affairs Compliance Pharmacist at Aspen Pharmacare PERegulatory Affairs Compliance Pharmacist at Aspen Pharmacare PE