Samah Sherif
Cairo,Egypt
Summary
Hardworking, highly skilled and self-organized (Qualified Person Responsible for Pharmacovigilance System) QPPV with 5+ years of comprehensive experience in pharmacovigilance field seeking a job opportunity in a reputable company where my academic background and interpersonal skills are well utilized and developed to contribute in both the company and my career progress.
Overview
8
8
years of professional experience
6
6
years of post-secondary education
1
1
Certification
Work history
Qualified Person Responsible for Pharmacovigilance (QPPV)
ClinMax CRO
10.2024 - 04.2025
- Continuous safety profile monitoring and benefit-risk evaluation of authorized medicinal products related to concerned MAHs
- Having an overview on the medicinal products safety profile and any emerging safety issues
- Having awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products
- Establishing, assessing and implementing risk management systems and evaluation of the effectiveness of risk minimization activities
- Collection, processing, management, quality control, follow-up for missing information, coding, classification, duplicate detection, evaluation and timely electronic submission of individual case safety reports (ICSRs) from any source
- Signal detection and signal management
- Ensuring conduct of pharmacovigilance system and submission of all pharmacovigilance-related documents in accordance with PVGA requirements – according to GVP in Egypt and in Arab Countries
- Scheduling, preparation, submission and assessment of periodic benefit risk evaluation report (PBRER) following the most updated EURD list and EDA PSUR supplementary list
- Providing any information relevant to the benefit/risk evaluation to the national regulatory authority
- Meeting commitments and responding to requests from the Pharmaceutical Vigilance General Adminstration (PVGA), including provision of correct and complete information as per guidelines for good vigilance practice in Egypt
- Communicating with MAHs' regulatory department with regards to updating the SmPC as per arising safety concerns
- Communicating information to healthcare professionals about changes to the risk-benefit balance of products for the aim of safe and effective use of medicinal products by updating the SmPC as per arising safety concerns
- Keeping product information up-to-date with the current scientific knowledge by performing regular literature reviews through regulatory authorities’ websites, international and local journals
- Preparation and submission of the addendum to the clinical overview (ACO) for concerned medicinal products
- Review and sign-off of protocols of post-authorization safety studies (PASS) conducted in the Arab Country concerned or pursuant to a risk management plan agreed in the Arab Country concerned
- Having sufficient awareness of post-authorization safety studies (PASS) requested by the national regulatory authority including the results of such studies
- Acting as a single pharmacovigilance contact point for the national regulatory authority on a 24-hour basis
- Developing and updating the standard operating procedures (SOPs) for assigned responsibilities
- Providing introductory pharmacovigilance awareness training to ClinMax employees
- Providing introductory pharmacovigilance awareness training to the employees of the contracted MAHs and its third parties
Vice Section Head - Deputy QPPV
Egyptian International Pharmaceutical Industries Company (EIPICo.)
07.2024 - 09.2024
- Responsible for being available 24 hours and performing all the QPPV duties in case of absence of the QPPV
- Responsible for timely planning, execution, submission, implementation and maintenance of PSMF, PBRER, RMP, ACO and national Displays at specific time periods or ad-hocs
- Responsible for writing PV Standard Operating Procedures
- Responsible for maintaining PV Agreements (PVAs), Contracts, Safety Data Exchange Agreements (SDEAs), preaudit plan and data analysis relevant to the company & quality compliance program
- Responsible for weekly and ad-hoc literature screening activities including global and local sources
- Responsible for managing PV activities at affiliate level, in line with the company & in line with the company’s procedures
- Responsible for fulfilling all the authority’s requirements concerning the Pharmacovigilance system
- Responsible for representing PV department during audits or regulatory authority inspections by actively leading and providing guidance and support as well as implementing corrective and preventive actions for the deviations
- Responsible for conducting training and revising documents prepared by newly hired PV members
- Responsible for providing Refreshment and Induction training sessions to all company’s employees
- Responsible for ensuring that all relevant documentation is adequately archived
- Responsible for collecting, processing and reporting ICSRs
- Responsible for receiving complaints from reporters
- Responsible for performing signal detection activities
- Responsible for performing internally and externally monthly reconciliation
Senior Pharmacovigilance Specialist - Deputy QPPV
Egyptian International Pharmaceutical Industries Company (EIPICo.)
10.2022 - 07.2024
- Responsible for being available 24 hours and performing all the QPPV duties in case of absence of the QPPV
- Responsible for fulfilling all the authority’s requirements concerning the Pharmacovigilance system
- Responsible for preparing the work plan
- Responsible for providing the required training for the new pharmacovigilance specialist and revising their documents before submission
- Responsible for weekly and ad hoc literature screening activities including global and local sources
- Responsible for revising and preparing PSMF, SOPs and pharmacovigilance documents
- Responsible for preparing for the audits and implementing corrective and preventive actions for the deviations
- Responsible for revising the received ICSRs on the database and following up if required in addition to collecting, processing and reporting ICSRs
- Responsible for following up on the received customer complaints
- Responsible for providing trainings to increase the awareness of the importance of reporting the adverse events
Pharmacovigilance Specialist
Egyptian International Pharmaceutical Industries Company (EIPICo.)
09.2020 - 10.2022
- Responsible for preparing PV documents such as (Risk Management Plans, Periodic Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, Work Instructions and Safety Data Exchange Agreements)
- Responsible for weekly and ad hoc literature screening activities including global and local sources
- Responsible for collecting, processing and reporting ICSRs
Pharmacist and Deputy Pharmacy Manager
Ezz El-Deen Pharmacy
09.2018 - 10.2019
- Responsible for providing consultation and answering inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects and specified use
- Responsible for dispensing medications
- Responsible for optimizing and enforcing pharmacy policies to maintain efficiency and responsiveness to demands
Pharmacist
Roshdy Pharmacy
07.2017 - 07.2018
- Responsible for providing consultation and answering inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects and specified use
- Responsible for dispensing medications
Education
Bachelor’s degree - Clinical pharmacy
Cairo University
01.2012 - 01.2017
MBA candidate - undefined
Paris ESLSCA business school
10.2024 - 04.2025
Skills
- Training and Mentoring
- Strong Communication Skills
- Leadership
- Coaching
- Presentation skills
- Time Management
- Problem Solving
Websites
Certification
- Egyptian Drug Authority, Literature Screening and MedDRA coding, 10/01/24
- MedDRA MSSO, Safety Data Analysis and SMQs, 08/01/24
- MedDRA MSSO, Coding with MedDRA, 08/01/24
- Insight-CRO, Signal Management and ESI, 02/01/24
- Egyptian Drug Authority, Pharmacovigilance Master file and Inspection, 01/01/24
- Egyptian Drug Authority, RMP and PBRER, 10/01/23
- Insight-CRO, Medical Devices Vigilance, 07/01/23
- Vigihub, P-Vigilances & Medical aspects of ADRs, 01/01/22
- Vigihub, Certified Qualified Person Responsible for Pharmacovigilance System (QPPV), 03/01/21
- Uppsala Monitoring Center, Statistical reasoning and algorithms in pharmacovigilance, 06/01/20
- Uppsala Monitoring Center, Signal detection and causality assessment, 05/01/20
- Vigihub, Certified Qualified Person Responsible for Pharmacovigilance System (QPPV), 11/01/19
- The American University in Cairo, Human Resource Management course, 01/01/19
Languages
Arabic
Native
English
Fluent
Timeline
Qualified Person Responsible for Pharmacovigilance (QPPV)
ClinMax CRO
10.2024 - 04.2025
MBA candidate - undefined
Paris ESLSCA business school
10.2024 - 04.2025
Vice Section Head - Deputy QPPV
Egyptian International Pharmaceutical Industries Company (EIPICo.)
07.2024 - 09.2024
Senior Pharmacovigilance Specialist - Deputy QPPV
Egyptian International Pharmaceutical Industries Company (EIPICo.)
10.2022 - 07.2024
Pharmacovigilance Specialist
Egyptian International Pharmaceutical Industries Company (EIPICo.)
09.2020 - 10.2022
Pharmacist and Deputy Pharmacy Manager
Ezz El-Deen Pharmacy
09.2018 - 10.2019
Pharmacist
Roshdy Pharmacy
07.2017 - 07.2018
Bachelor’s degree - Clinical pharmacy
Cairo University
01.2012 - 01.2017
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