Our Client, a multinational pharmaceutical company, is looking for a Regional PV Specialist to join their ever-growing team in Cairo, Egypt.

Job Summary

• To fulfill the requirements of the local Egyptian legislation for pharmacovigilance.

• Acting as national QPPV/Local Safety Responsible as required and a single pharmacovigilance contact point in Egypt towards the Egyptian Competent Authority on a 24-hour basis and also as a contact point for pharmacovigilance inspections.

• Acting as national QPPV/Local Safety Responsible as required and a single pharmacovigilance contact point wherever required and as accepted by Competent Authorities (CAs) in Africa and assigned countries towards the appropriate CAs on a 24-hour basis and also as a contact point for pharmacovigilance inspections.

• Within the frames of the Middle East and Africa (MEA) PV team acts as the primary PV local contact responsible for all pharmacovigilance activities for assigned countries of responsibility in the African region.

• Within the frames of the Middle East and Africa (MEA) PV team acts as PV backup contact responsible for all pharmacovigilance activities that may be needed to be performed during the backup period in the Middle East and assigned countries.

• To act as the company’s PV contact for vendors and distributors from assigned countries of responsibility.

• Have an overview of the company pharmacovigilance system described in the Pharmacovigilance System Master File (PSMF) and the Egyptian pharmacovigilance system as described in the Pharmacovigilance Subsystem File (PSSF). Have an overview of other African PSSFs where required.

• Collaborate with GPS, EU QPPV, and regional cluster head to maintain an efficient PV system meeting regional and national regulations and in compliance with the company’s PV procedures.

• To keep awareness and updated on relevant national Egyptian and assigned countries’ PV legislation, including requirements for reporting of ICSRs, and inform regional cluster head and global patient safety team about any relevant changes to the PV legislation.

• Ensure appropriate contact with the country/region general manager and other interfaces not limited to country regulatory affairs, country quality assurance, business units, and with healthcare professionals and competent authorities in Egypt and assigned countries.

• Working closely with the regional cluster head in each pharmacovigilance aspect.

• Outlining and representing the company’s corporate expertise and opinion towards local CAs.

• Support answering questions or requests related to pharmacovigilance from Egypt and African CAs in close collaboration with the regional office and cluster head.

• Escalate to regional PV head, cluster head, EUQPPV, and global patient safety any safety-related issues arising` in Egypt or Africa without delay.

• Performing surveillance activities for any new potential safety information (e.g., similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalating as per procedures.

• To be a member of the local pharma association and actively participate in meetings, if applicable.

• Assignment of countries of responsibilities may change if required by business or pharmacovigilance needs.

Responsibilities

Activities related to the main country Egypt, the African region, and all assigned countries:

• Identifying, implementing, and maintaining local processes and documents (procedures, instructions), building an efficient local pharmacovigilance system in Egypt and assigned countries, meeting CAs’ and countries’ PV legislation requirements, and in compliance with the company’s pharmacovigilance procedures.

• Contribution to the quality management system.

• Reviewing and updates to the internal system.

• Preparation, maintenance, and approval of PSSFs in assigned countries as required by local legislation.

• Knowledge of local PV legislation in the African region.

• Periodic review and documentation of local authorities’ websites in the African regions and assigned countries.

• Awareness of local reporting rules in Egypt, the African region, and assigned countries, changes to them, and immediately informing the regional PV head and global team about these requirements.

• Receipt of ICSRs and any other reportable information from any source, documentation, follow-up (if needed with special forms) and registration in the global database following the company’s global procedures and within timelines.

• Submission of ICSRs to Egyptian and assigned countries’ CAs timely and according to their requirements. Answering subsequent questions from CAs in collaboration with the EMEA cluster head.

• Answering questions from HCPs with support or global patient safety and in collaboration with the EMEA cluster head.

• Answering questions and requests from Global Patient Safety promptly.

• Searching of local journals in Egypt, the African region, and assigned countries.

• Training on PV of the company’s new employees upon their arrival and customer-facing employees yearly or as needed by local regulations.

• Training on PV for any third parties bound with the company with safety agreements in Egypt and assigned countries with agreed frequency as indicated in the agreement.

• Archive training documentation.

• Keep up-to-date own training records.

• Awareness, an overview of safety agreements with the company’s partners in Egypt and assigned countries, and fulfillment of specified activities including but not limited to the exchange of ICSRs and periodic reconciliation.

• Review of local SDEAs as per internal process.

• Having an overview and access to the current local PSUR schedule from regulatory affairs.

• Submit PSURs to the Egyptian competent authority.

• If needed and according to an established local process, validate the comparative table prepared by regulatory to put CCDS/CCSI/RSI and local SmPC in conformity.

• Awareness, an overview of and review of safety sections local PSP/MRPs, RMPs, PASS-protocols, and fulfillment of specified activities if applicable locally, for example, risk minimization measures to be implemented locally.

• Ensure appropriate contact with the country/region general manager and other interfaces not limited to countries’ regulatory affairs, quality assurance, business units, and with healthcare professionals and competent authorities in Egypt and assigned countries.

• Bringing safety expertise and advice to other local functions when needed.

• Review local safety communications.

• Participation in all safety issues with products in Egypt and assigned countries, emerging safety concerns, and safety variations.

• Act as a contact point for inspections in Egypt and assigned countries.

• Participation in internal and external audits as per plan.

• Monitor and ensure local compliance, and make efforts to achieve high compliance rates.

• Participation in CAPA, initiation, and FU of CAPA.

Activities related to other countries in the MEA region:

• Being part of the MEA PV team.

• Provide support to MEA countries in different aspects of pharmacovigilance as requested.

• Providing PV back-up for the national QPPV/LSR/primary PV contact in assigned countries, including receipt of AE reports from any external/internal sources, case intake, submission to local MOH and partners where required (i.e., by checking PV database on daily bases and performing submissions within deadlines).

• Performing quality check of cases in which intake was performed by primary PV contact.

• Travelling to countries assigned as national QPPV/LSR/primary contact and other MEA countries according to pharmacovigilance and business needs.

Qualifications & Skills

• Minimum bachelor’s degree in pharmacy or medicine.

• Experienced in Pharmacovigilance for at least 3 years.

• Knowledge of Egyptian and Arab League pharmacovigilance legislation and guidelines.

• Fluent in English and Arabic.

• French language would be an advantage.

• Risk identification and problem-solving.

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At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within max. 5 working days. If you don’t hear from us, please consider your application unsuccessful on this occasion.

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