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Job Description
- Establishing, maintaining and managing Pharo Pharma Pharmacovigilance (PV) system.
- Has access to the pharmacovigilance system master file (PSMF) and he has the authority to ensure and verify that all the contained information is an accurate and up-to-date reflection of our PV system.
- Preparation, revision and responsible for submission of All Pharmacovigilance documents (PBRER, RMP, ACO, DHPC) to the Egyptian Pharmaceutical Vigilance Center (EPVC) within the specified time frames.
- Is involved in the revision and sign-off of protocols of post-authorization safety studies (PASS) conducted in Egypt or pursuant to a risk management plan agreed in Egypt (when requested by EPVC);
- Committed to EPVC meetings and in responding to all EPVC's requests including provision of correcting or completing information.
- Deliver trainings and mentoring Pharmacovigilance staff.
- Deliver trainings to customer facing non-PV staff on the perfect way to collect Case Safety reports and report them to PV team within the specified timeframe.
Job Requirements
- Graduated from faculty of Pharmacy.
- 5-7 years of Pharmacovigilance experience.
- Finished all related PV training courses.
- Very good command of English Language.
- Very good Computer skills (Microsoft office and internet searching).
- Communication and presentation skills.
- Leadership skills.
- Stick to tight deadlines and work under pressure.
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