Waleed Abdul Moniem Mohamed

1-Regional Pharmacovigilance Specialist at Fresenius Kabi 

(Middle East & North-East Africa)

(LSR Egypt) 

(NSO Middle East)

(KSA, UAE, Kuwait, Jordan, Oman, Syria, Palestine, Iran, Sudan, Libya, Yemen, Qatar, Iraq)

01 Nov 2021-----Present

Maintain NSO and NSO deputy information .

• Maintain Other personnel performing PV activities.
• Keep & record Attachments to other personnel performing PV activities.
• Manage ADRs received and entrance on Kabisafe, and reporting of relevant ADRs to concerned authorities.
• Manage Social Media Manager information when applicable. Keep an overview of generic email addresses.
• Perform Local literature search including regularly check in the authority website and ADR data basis.
• Create & maintain Local PSP Registry when applicable.
• Overview & maintain Company-sponsored studies, non-interventional studies, and websites/chatrooms when applicable.
• Maintains all PV activities and details about local procedures.
• Overview PV activities outsourced to PV Service Providers when applicable.
• Initiate & maintain PV Agreements with distributors.
• Keep up to date list of Distributor products.
• Maintain & record all Pharmacovigilance System Performance.
• Maintain & record all ICSRs including Expedited reporting - Key Performance Indicators.
• Maintain & record Expedited reporting - Late processing Maintain & record Expedited reporting - Late reporting.
• Maintain all PSURs including a List of all local and global PSURs submitted & parts created locally (including details on late submissions)
• Maintain & record submission of Periodic Safety Reports (PSURs, PADERs) - Key Performance Indicators.
• Responsible for Safety variations and Risk Management Plans including the parts created locally.
• Responsible for safety label changes.
• Recommend terminating any distributor's agreement in case of any critical risks affecting patient safety.
• Be up to date with the Organigram of description of MU structure.
• Handling PV inspections from authorities.
• Responsible for submission and implementation of safety variations.
• Maintain & record a List of all Risk Management Plans submitted.
• Maintain, record & monitor the timely implementation list of additional Risk Minimization Activities.
• Responsible for PV Training including PV Training received and given.
• Responsible for PV Audits on distributors including Annual PV Audit Plan -Details of PV Audits -PV Audit Findings.
• ePUR preparation, updates & submission to corporate.
• Maintain all Computerized Systems and Databases (GCMW- e-PUR - Kabisafe - Excel tracking sheets, etc).
• Manage quality Complaints follow entrance in GCMW and deliver customer final feedback in a timely manner, complete complaint KPI and perform the role of the complaint officer.
• Responsible for CAPA creations on Kabitrack relevant to PV & complaints.
• Act as 24 hours point of contact.
• Responsible for medical device vigilance.
• Medical inquiries review & re-conciliation.
• Monitoring the pregnancy cases & keeping a pregnancy register.
• Creation and update of relevant SOPs.
• Follow-up on the new country(es) regulations & guidelines for pharmacovigilance.
• Follow up the corporate and local requirements related to compliance to the guidelines and legal obligations in respect to patient safety.
• Handling any communications with authorities (PV inspections, receiving PV letters issued from the authorities)

Perform periodic reconciliations with the approved distributors and with the Marketing team on the Adverse Drug Reactions received during the reconciled period.

1-Regional Pharmacovigilance Specialist at Fresenius Kabi 

(Middle East & North-East Africa)

(LSR Egypt) 

(NSO Middle East)

(KSA, UAE, Kuwait, Jordan, Oman, Syria, Palestine, Iran, Sudan, Libya, Yemen, Qatar, Iraq)

01 Nov 2021-----Present

Senior Pharmacovigilance Officer at Hikma Pharmaceuticals

"Deputy Local Safety Responsible"  01 Sep 2018 – 31-Oct-2021

Cardiovascular and Diabetes Product Specialist. Hikma Pharmaceuticals, Cairo (Egypt)

1 Mar 2009–31 Aug 2018 

1. Pharmacovigilance Specialist Certificate in GVP & Pharmacoepidemiology 

4 Aug 2018–8 Oct 2018

Licensing Body: Arab Union of the Pharmaceutical Manufacturers

Lecturer: Dr. Amr Saad, Former Head of the Egyptian Pharmaceutical Vigilance Center

Scope: Pharmacovigilance

Master of Business Administration (MBA)

Al-Azhar University in Cairo. Egypt. 7 May 2016 Major: Business Administration

1. Bachelor in Pharmaceutical Sciences & Pharmaceutical Industries

Faculty of Pharmacy, Cairo University, Egypt 2002 Major is Pharmacy