ABOUT YOU:

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

• Experience: Experience with pharmacovigilance systems and safety related product management.
• Skills: Robust understanding of national PV regulations regarding safety requirements, Pragmatic, solution oriented mindset, problem-solving, prioritize, detail-oriented, and meet challenges.
• Education: Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, Mph or Master Degree with two or more years of pharmacovigilance experience.
• Languages: Fluency in English and German language.

SUMMARY

• Type of job:Full-time
• Location:Hungary
• Capability:Pharmacovigilance & Safety

• 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.