Engy Hassan

• Acts as the Affiliate’s lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PSEQ (Pharmacovigilance and Patient Safety, Epidemiology and Research & Development Quality Assurance) function.
• Facilitated open communication channels between employees and management regarding safety concerns, promoting a transparent work environment.
• Served as a trusted resource for colleagues on safety-related topics, addressing questions and concerns promptly and knowledgeably.
• As People Leader: To provide strategic leadership to manage and support the Pharmacovigilance (PV) team in executing assigned responsibilities.
• Oversight of the Pharmacovigilance System by maintains oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by PSEQ Regional PV Teams and/or outsourced partners
• Affiliate Lead and point of contact for affiliate PV audits and Regulatory Authority PV inspections, demonstrating understanding of the overall AbbVie PV system and how Global PV processes and PSEQ Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements.

• Act as Local safety responsible ( LSR) for Egypt
• Act as a single PV contact point for the competent authority (ies) of Egypt 24 hrs basis and also a contact point for PV inspections
• Have an overview of medicinal product safety profiles and any emerging safety concerns;
• Oversight of the Creation and maintenance of the local PSMF/PSSF;
• Maintain awareness of Pharmacovigilance regulatory requirements and developments;
• Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance- related documents in accordance with the legal requirements and Good Vigilance
• Practices
• Support MEA case managemnet team to fulfill the responsibility for the execution of all aspects of PV individual case safety reporting (ICSR) processing to ensure that all of AbbVie's statutory and ethical responsibilities are met.

• Middle East & Africa - MEA, Accountable for Pharmacovigilance and products safety in all MEA countries portfolio for both legacies Allergan and AbbVie products

Risk Management

• Performs product-specific benefit-risk activities and support in overseeing the safety profile of Abbvie MEA medicinal products in clinical development and those authorized and marketed, including devices and combination products
• Reviews global risk management plan (RMP) and advises on local impact.
• Collaborates with BR & TA Lead in the preparation of affiliate risk management team (ARMT) Meetings when required. Create local implementation plan (LIP) and ensure timely completion.
• Creates and review local RMP annex for assigned products.
• Submission of Risk Management related documents to regulatory authority.
• Tracks Risk Minimization Tool distribution and measures effectiveness when required.
• Implementation of relevant LIP and accompanying additional risk minimization tools (RMz), when and where applicable.

Periodic Safety Reporting and Development Safety Reporting

• Reviews periodic safety update reports (PSUR)/ drug safety update reports (DSUR) /Line listings and advise on local impact.
• Prepares local PSUR annex when applicable.
• Prepares cover letter and submits to Regulatory authority/Ethics Committees or Investigators when applicable.
• Advises functional lead on aggregate report schedule updates

Product Safety Monitoring & Therapeutic Area

• Develops a relevant knowledge of the therapeutic area (TA) - disease knowledge, product knowledge, the safety profile, the benefit risk information, and the therapeutic landscape.
• Submission of significant safety issues to local regulatory agency.
• Reviews of safety data collection requirements for research activities (i.e., investigator-initiated studies (IIS), non-interventional studies (NIS), collaborative studies etc.) when applicable.
• Reviews of study protocol (Clinical & post marketing observational studies (PMOS), Registry summary report, Clinical Safety reports, investigator-initiated studies (IIS) outputs when applicable.
• Builds strong partnerships and work collaboratively with stakeholders and other functions across the business, such as Regulatory Affairs, Medical Affairs, Brand Teams, as applicable.
• Performs surveillance of Local Safety Information and communicates to affiliate medical director (AMD) and pharmacovigilance & patient safety (PPS) for escalation and evaluation.
• Oversights & internal communication of product safety updates, local safety data trending and monitoring activities.

This role is responsible for the day-to-day ICSR activities related to:

• Case Intake and Triage including seriousness check, Trilogy entry and case processer allocation.
• Case submission to authorities including CT, etc.
• Case QC.
• Follow-up Process.
• Case Processing & Archiving.
• Quality Reviews with internal partners
• Quality Control Check (QCC) with service providers.
• Reconciliations
• Metrics/Dashboard entry
• Review the result of the Literature Surveillance and Quality Review

• Act as PV contact point with corresponding local authorities on 24-hour basis
• Have an overview of medicinal product safety profiles and any emerging safety concerns;
• Create and maintain PSMF/PSSF;
• Maintain awareness of Pharmacovigilance regulatory requirements and developments;
• Perform weekly scientific literature screening and report identified ADRs;
• Identify, collect and report adverse events (ICSRs);
• Conduct all internal required training as per training plan;
• Create and adapt SOPs as required
• Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance- related documents in accordance with the legal requirements and Good Vigilance
• Practices
• Read and acknowledge all necessary company standard operating procedures (SOPs)

• Establish, maintenance Pharmacovigilance system and interaction between it and product quality systems
• Manage the interactions between the Pharmacovigilance and other departments
• Perform the Pharmacovigilance system master file (PSMF) and ensure that the information contained in it is accurate and up-to-date
• Establishing, assessing and implementing a risk management system and evaluating the file effectiveness of the risk minimization by preparation and submission of risk minimization plans (RMP) for all products
• Collection, processing, management, validation quality control, follow up for missing information, coding, classification, duplicate detection and archiving of individual case safety reports (ICSRs)
• Scheduling, preparation, submission and assessment of periodic bene t/ risk evaluation report (PBRER)
• Communication about safety concerns between marketing authorization holders (MAH) and national medicines authorities, in particular, notifying changes to benefit- risk balance of the medical product.

• Work closely with medical and nursing staff to make sure hospital patients receive the best treatment, advising on the selection, dose and type of administration
• Provide help and advice to patients in all aspects of their medicines
• Developing clinical pharmacy programs according to policies and regulations
• Reviewing records of patients to determine the appropriateness of medication therapy
• Evaluating patients condition to ensure all issues are being treated.

• Develop a method to test new chemical entities and impurities/degradations in the finished products
• Prepare valid methods of analysis for required pharmaceutical products including finished product, API, and excipients
• Analyze organic and inorganic compounds to determine chemical and physical properties
• Co-ordinate with Quality control department to smoothly transfer the method to the
• QC department
• Follow up stability plan for R&D samples and production batches
• Prepare the Stability protocol and stability reports
• Analyze R&D trials to achieve Final formula for planed products.