Drug Safety Specialist – Hungary

Job Title: Mission Safety Member

Location: Hungary

Type: Remote

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

The person who will join Excelya, will be the Pharmacovigilance Responsible Contact person for Hungary and the deputy Pharmacovigilance Responsible Contact person for Austria and Switzerland.

Main Responsibilities:

• Serves as the local PV contact for the authorities, is accountable for PV inspections and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CLIENT products where applicable per national regulations.
• Is recognized as the key leader for all PV related activities at country level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs market research programs for PV aspects.
• Ensures that local PV activities in the assigned country are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CLIENT products on the market in the assigned country.
• Establishes and maintain robust and efficient local PV systems in the designated country by ensuring the availability and implementation of proper systems/procedures tools and training. Support the QPPV in overseeing the PV activities in the country.
• Support the CLIENT Head of Safety with regards to local budget planning and management.
• Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.
• Acts as Deputy CSH for partner countries.