Job duties:
- Prepare all required PV documents and reports and get EDA approval.
- Working in a cross function culture with different departments e.g. Sales , registration, marketing, and R&D to complete all required pharmacovigilance tasks.
- Receiving any reports of any adverse effects of the company's products then entering them on data base and submit them EDA .
- Reviewing recent studies and evaluating the effectiveness and safety of Products.
- One of the main points of contact with EDA regarding the pharmacovigilance system.
- Preparing SOP for pharmacovigilance practice and all related company requirements.
- Searching for reference and non-reference products in different authority sites or other sites.
- Receiving quality defects complaints of any of the company products received from commercial teams , HCP or patients and sending them to the R&D and quality assurance departments to take CAPAs.
- Regularly updating all PV documents and sending them to the PV Department at EDA, with all requirements.
- Participate in Medical training of the commercial teams and all other requested medical activities.
- Participate in leaflets creation and updates and all other required scientific documents for Reg. purposes.
- All other assigned medical affairs / PV tasks.
Qualifications, experience and skills required
- Physician /Pharmacist ONLY
- 1-3 Years of Experiences in the same or relevant field.
- Excellent Medical background.
- Certified PV person. (partial / Full PV courses or PV Diploma / Clinical Pharmacy Diploma)
- English (spoken and writing skills).
- Microsoft office skills and other computer skills and internet surfing.
- Planning& organizing Skills with very Good presentation skills.
