Aya H.
Pharmacovigilance and Regulatory affairs Specialist at Novell Pharma- Claim this Profile
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Arabic Native or bilingual proficiency
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English Professional working proficiency
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German Elementary proficiency
Topline Score
Bio
Credentials
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Professional regulatory affairs course
Nawah ScientificOct, 2022- Nov, 2024 -
Pharmacovigilance training course
VigiHubOct, 2021- Nov, 2024 -
Pharmacovigilance training course
TRegiViraSep, 2021- Nov, 2024 -
Causality assessment, Introduction to signal detection
Uppsala Monitoring CentreJul, 2021- Nov, 2024 -
Pharmacovigilance training course
PDRTCJun, 2021- Nov, 2024 -
PTE
Pearson VUENov, 2019- Nov, 2024 -
KAPS exam
Australian Pharmacy CouncilMay, 2019- Nov, 2024 -
IELTS exam
British CouncilJan, 2016- Nov, 2024
Experience
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Novell Pharma
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Egypt
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Pharmacovigilance and Regulatory affairs Specialist
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Jul 2021 - Present
- A PV specialist for a marketing authorization agent. - Processing and assessment of new and follow-up reports of adverse events. - Assisting with the preparation of the audit/inspection and participating in the audit/inspection. - Communication with abroad MAHs and regulatory authority. - Preparing Pharmacovigilance system master file (PSMF) - Preparing Pharmacovigilance and Quality SOPs for PV department. - Assisting in preparing of local RMP. - Performing literature screening process. Show less
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Quality Control Microbiologist
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Feb 2020 - Feb 2021
- Prepare and test samples from all phases of pharmaceutical manufacturing or other handling processes, with the goal of determining if the (sterile or non-sterile) substance meets the microbial limits or requirements according to USP/FDA guidelines.- Conduct routine microbiological assays such as bioburden and water testing.- Collect and test environmental monitoring samples.- Maintain up to date documentation and (SOP's).- Support sampling and testing for cleaning validation and analysis methods validation- Participates in training of other employees and trainees. Show less
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Quality Assurance Specialist
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May 2011 - Jan 2020
- Coordinate with the manufacturing department in controlling their process and products at every stage of manufacturing to meet the established specifications.- Conduct regular investigations to guarantee that workers follow safety procedures.- Review the final batch production record of each batch of finished product.- Ensure compliance of plant conditions (Humidity, Temperature, etc.) according to guidelines.
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Education
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2014 - 2015
Faculty of pharmacy, Cairo University
Diploma, Industrial pharmacy -
2011 - 2012
Faculty of pharmacy, Cairo Univeesity
Diploma, Quality control and Quality assurance -
2005 - 2010
Cairo University
Bachelor’s Degree, Pharmacy and Pharmaceutical Sciences
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