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Job Description
- Responsible for maintenance of the pharmacovigilance system and the quality system and the pharmacovigilance activities
- Keeps permanently updated The Good Pharmacovigilance Practice for Arab Countries.
- Having an overview of medicinal product safety profiles and any emerging safety concerns
- Having awareness of any obligations adopted and other commitments relating to safety of the products
- Having awareness of risk minimization measures;
- Having sufficient authority over the content of risk management plans;
- Having awareness of post-authorization safety studies.
- Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the national legal requirements and GVP in Arab countries;
- Ensuring a full and prompt response to any request from the national medicines authorities
- Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. Variations, urgent safety restrictions, and communication to patients and healthcare professionals);
- Contact with the EPVC representatives to ensure the contact of all safety-related matters potentially impacting Egypt
- Ensure that any inquiry from EPVC is answered fully and promptly.
- Collaborates with Quality Assurance, in monitoring of compliance for expedited individual and periodic aggregated data reporting, protocols, Standard Operating Procedures, database operations, training of personnel and in the identification of corrective actions and there implementation where appropriate.
- Ensures that he/she is promptly notified of potential or actual signals/changes in the safety profile of products.
- Partner the data entry site to support the relevant functions in the electronic submissions of the Individual Case Safety Report (ICSR)
- Perform all PV activities stated in The Good Pharmacovigilance Practice for Arab Countries & be compliant with competent authorities regulation.
Job Requirements
- Bachelor degree of pharmacy.
- Pharmacovigilance training.
- Proven good oral and written communication skills.
- Good understanding of computer technology and management of relational database systems.
- Understanding of product development and clinical research.
- High skills in time management and organization.
- Fluency in written and verbal English.
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