Medical & PV 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 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.