Medical & PV Affairs Advisor

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 ONLY1-3 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.