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Job Description
- FREELANCE / PART TIME
PHARMASTARS is looking for a reliable Freelance PV specialist with proven experience in the Pharmacovigilance field to carry on the following tasks for PHARMASTARS products and to be the QPPV for the company.
- Prepare and Submit PV New Drug Application file, PV Renewal file, PSUR, RMP, ACO, and any other Pharmacovigilance related files to EDA.
- Monitoring the safety profiles of our marketed products and addressing any emerging safety concern
- Conducting pharmacovigilance training for internal employees and external partners and onboarding new employees.
- Handling pharmacovigilance cases, customer complaints, and adverse events for marketed products and ensuring the overall compliance of PV activities to the local and global regulations as applicable.
- Ensuring compliance with local and global regulations related to pharmacovigilance activities.
Job Requirements
- Certified QPPV to work with EDA
- 2-5 years experience in pharmacovigilance
- Knowledge of Egyptian and global pharmacovigilance regulations.
- Attention to detail and high accuracy in data handling.
- Ability to work independently and meet deadlines.
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