Clinical Safety Physician

Founded in 1946 Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care and Specialty Care.

With the aim of strengthening our Corporate Pharmacovigilance Team in Egypt, we are recruiting a

Clinical Safety Physician

The candidate will provide medical advice to the Clinical Project Teams for the planning, conduction and reporting of clinical studies developing study protocols, study reports and discussing with CROs and Vendors the Safety Management Plans and other Study Plans (e.g. Data Management Plans), subject enrollment, subject's safety, responses to Competent Authorities.

Main responsibilities:

• Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to drugs, medical devices, food supplements and cosmetics under study, identifying and assessing any safety risks associated with study products and making recommendations for managing or mitigating those risks.
• Being responsible for the overall safety of the product, from preclinical development to post-approval and Supporting the Clinical Safety & Risk Management Manager in performing the medical review and assessment of Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs), Suspected Unexpected Adverse Drug Reactions (SUSARs).
• Collaborating with Study Team Members of the drug development program, including CROs/Vendors, Statisticians and Data management, Corporate Clinical and Preclinical Development department, to ensure that safety issues are adequately addressed.
• Participating in the development of risk management plans (Drug Development Risk Management Plans) which outline strategies for minimizing the risk and contributing to the review and approval of protocols, benefit/risk profile, study reports and any safety update reports.
• Contributing to the preparation of regulatory submissions and responding to questions from regulatory agencies regarding the safety and efficacy of products.
• Participating in ongoing safety surveillance programs to monitor the product safety under development and during the Product Life Cycle Management.
• Collaborating with Data Monitoring Committees to ensure that data have been reviewed before the review by the Data Monitoring Committees. Participating to the Data Review Meetings, Data Reconciliation and Data Reporting.
• Acting as a backup for the Risk Management Physician.

Requirements:

• University Degree in Medicine and Surgery
• 7-10 years of experience in Pharmacovigilance
• Knowledge of Clinical Development Processes for drugs and preferably medical devices
• Knowledge of GVP, PV Legislation and related guidelines
• Specialization in pharmacology and work experience in clinical research are preferred
• Proficient knowledge of English language, written and spoken
• Analytical, communication and team working skills

Our offer:

• Open-ended contract
• Salary between 600.000 and 650.000 EGP

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.