Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint care, Eye care, Skin care, Specialty care, Health&Wellness care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries.With the aim of strengthening our Global Pharmacovigilance Team in Egypt, we are recruiting aCorporate PV Operations SpecialistThe candidate will perform the ongoing management of Pharmacovigilance operations relevant to Fidia’s products, collaborating with the Corporate PV Operations & Data Governance Manager.Main responsibilities:Processing all medical complaint cases regarding Fidia products (medicinal products for human use, medical devices, cosmetics, food supplements, etc.) received from any sources.Performing quality control activities to ensure complete and accurate data entry into the safety database.Submitting case reports to Health Authorities and/or partners in compliance with the due timelines.Contributing to the production of line listings and summary tabulations for safety reports (PSURs, DSURs, PBRERs, Annual Safety Report, etc.).Performing Signal Detection extractions from BI Module according to company strategy defined by the Head of Corporate Clinical Safety, Pharmacovigilance and R&D Compliance.Writing and reviewing SOPs and Working Instructions according to national and international guidelines and regulations.Contributing to Audit/Inspections readiness and implementing Corrective and Preventive Actions (CAPAs).Performing periodic reconciliation of safety data with Third Parties, Subsidiaries, and involved Fidia Departments (e.g., Corporate Medical Affairs, Corporate Quality Assurance, Communication Department).Contributing to the administration of the safety database and coordinating technical and validation activities, including Data Migration Projects.Contributing to the management of PV operations and Data Management with the Safety Database, as well as performing XEVMPD and MedDRA Dictionary updates.Requirements:Degree in Pharmacy, Pharmacology, Pharmaceutical Chemistry, Biology, Biotechnologies or other scientific related fields.Minimum of 3 years of experience in Pharmacovigilance management system and Safety Database Management.Knowledge of GVP, PV Legislation and related guidelines, as well as PV operational procedures and Safety Database Management for Case Processing.Good knowledge of Microsoft Office.Fluent in English.Attention to detail, critical thinking, planning, organizational and teamwork skills.Our offer:Permanent contract with Fidia Egypt.Annual Gross Salary between 359.000 - 448.800 EGP.Fidia benefits:In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, staff discounts and access to the flu vaccination campaign.Fidia Farmaceutici promotes parity and inclusion in all its actions.All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age. All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.We are upgrading our recruitment platform to improve your candidate experience.From May 25 to June 15, the platform will be unavailable and it will not be possible to access or submit applications.By submitting your application via email, you acknowledge that you have read the privacy notice available here.