RASHA TAWFIK

• Processing, case Intake, tracking, follow up and forwarding of AE and
• Special Situations concerning medicinal products, cosmetics, biocides, and medical devices (when registered locally/regionally as drugs) with or without Product Technical Complaint to Global
• Pharmacovigilance & Risk Management or partner (as applicable); Manage Certifications
• Certified QPPV UAE & Oman
• MOH license
• Arabic native, Fluent English reconciliation activities and documentation of cases identified through reporting, literature and all other potential sources to GPRM
• Responsible for identification of outsourcing needs, oversight and general end-to-end set-up of PV Operations, oversight external PV service provider to ensure high quality and compliant of PV activities
• Mange MEA affiliate(s) and/ or partner regulatory designee(s) with expedited safety reports or aggregate reports for submission to local health authorities for assigned territories, documentation thereof
• Manage PV activities in assigned territories to support of and review periodic safety reports, aggregate reports Periodic Safety Update Reports (PSUR), Periodic Benefit Risk Evaluation Report (PBRER)
• Monitor post marketing safety data to identify issues, trends and/or signals
• Communication of identified safety issues to manager and or other
• GPRM colleagues
• Monitor PV data on country Health Authority websites and check for changes in local/regional regulatory environment, updating PV System (including SOPs) accordingly
• Notify GPRM and EEA QPPV, in coordination with Regional Head, of any changes which may affect global processes or exchange of safety information within GPRM or with partners
• Develop, review and maintain of local PV SOPs/ Regional SOPs/Work
• Instructions/ PSSF, vendor Service Agreements, and ensures content alignment with GSOP and Local PV requirements; ensures regular updates of these documents as per established review cycles and as required according to enhancement needs
• Responsible for onboarding, develop training materials and conduct training for new hires, local affiliates and to third party distributors or vendors within the assigned territories on drug safety reporting to meet company SOPs, local and international laws, and guidelines, as required
• Maintains constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates efficient and compliant functioning of local PV structure
• Leads pharmacovigilance audits and inspections in region from external notified body, regulatory agencies, or corporate auditors
• To notify GPRM PV Compliance Team and
• EEA QPPV of any Local/Regional Health Authority Inspections
• Assist in maintaining global PSMF up to date for MEA Region, coordinating with GPRM
• Prepare SDEA/PVA for MEA as SDEA designee for region
• Work in collaboration with regional stakeholders commercial, marketing, regulatory, quality, HR and legal teams to maintain PV activities in compliance to local & global legislations
• Manage in collaboration with local Finance and Global Management budget and resource planning for local PV activities
• Act as active member in regional PV society, support on planned changes to PV Regulation in close collaboration with regional PV society
• Anticipate changes in PV Regulations and plans for changes in local procedure and templates as per needed.

• Mange ICSR processing, case Intake, tracking, follow up and forwarding of
• AE and Special Situations concerning medicinal products, cosmetics, biocides, nutritional’s and medical devices (when registered locally/ regionally as drugs) with or without Product Technical Complaint to Global
• Pharmacovigilance & Risk Management or partner (as applicable); Manage reconciliation activities and documentation of cases identified through reporting, literature and all other potential sources to GPRM
• Oversight external PV service provider to ensure high quality and compliant of PV activities
• Authors and maintains PV-related training
• Authors local documents, such as Standard Operating Procedures (SOPs)
• Guidelines, Safety Management Plans/Manuals
• Support PV system maintenance and keep audit / inspection readiness state.

Handling new product registration including preparation & compilation of (eCTD) Structure, product pre-launch registration, product Life Cycle Maintenance (renewals and minor variations of pharmaceutical Products & general sale list items ).

• Handling KSA market Projects creation, submission, renewal and variation, actively (achieved 10 regulatory project and work to Finalize approvals.)

• Handling EAC region (Kenya, Uganda, Rwanda and Tanzania), Ethiopia and Egypt responsible for new submission and all regulatory requirements.

• Ensuring submitted projects documentation will fully meet the different regulatory requirements.

• Working on different software for eCTD compilation, and work on our D2 & Amplexor databases document & SOP management

• Revision of products labelling & packaging data as per guideline for each country.