Deputy QPPV
Full time posted 2 months ago in Health Care Shortlist Email JobJob Detail
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Job ID 10348
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Career Level Entry Level/Junior Level / Fresh Grad
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Education Level Bachelor\'s Degree
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Industry Pharmaceutical
Job Description
- Maintain pharmacovigilance (PV) system, including all activities which contribute to the detection, assessment, reporting and communication of safety information, as well as risk management activities.
- Search, and prepare sign-off of protocols of post-authorization safety studies conducted in the European Union (EU) or pursuant to a RMP agreed to in the EU.
- update the pharmacovigilance system master file (PSMF) is constantly an accurate and up-to-date reflection of that safety system
- Preparing risk management plans and other PV documents of the products required for registration and Re-reg (as a part of the registration process) or upon authority request at any time.
- Preparation of periodic safety update reports of the assigned products (PSUR) and submit them to the EPVC timely, according to the (EURD) schedule.
- Receive, Analyze and initially process product complaints Collaborates with Quality Assurance, in monitoring of compliance for expedited individual and periodic aggregated data reporting, protocols, SOPs, database operations, training of personnel and in the identification of corrective actions implementation where appropriate.
- Ensuring conduct and submission of all pharmacovigilance-related documents in accordance with the national legal requirements and GVP in Arab countries;
- Collaborates with relevant functions internally to ensure an adequate level of awareness and education of Zeta pharma employees, including medical representatives, as regards safety matters, safety data collection and reporting.
- Participate in preparation and review of all promotional materials from medical point of view.
- Attending medical conferences and other scientific events when needed to get feedback and support the sales and marketing teams.
- Prepare and maintain references and other Medical Information resources.
- Support the regulatory department in any requested medical data and preparation of any reg. documents
- Archiving and storage of all the information and reports of the company and make sure that it is easily accessible and the required information is available at any time.
Requirements:
- Bachelor’s degree in pharmacy or medicine.
- from 6 months to 2 years of experience in in the pharmaceutical industry as QPPV or member of PV.
- QPPV preparation course is a preferred.
- MS Office Suite: Advanced user
- Typing skills: Advanced user
- ERP software: Advanced user
- Practical experience of literature search, medical writing, quality monitoring of PV activities and in implementation of additional safety issues.
- Knowledge of principles and processes for providing customer and personal services.