Drug Safety Officer

at  Excelya

MINIMUM REQUIREMENTS :

• At least 2 years of experience in pharmacovigilance/clinical development, pharmacovigilance systems and safety related product management.
• Appropriate experience with Regulatory Agency interactions.
• Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree will be a plus.
• Knowledge of national PV regulations and international regulations regarding safety requirements as well as industry standards.
• Pragmatic, solution oriented mindset, problem-solving, prioritize, take initiative and meet challenges.
• Good written and verbal communication skills in English and local language are required.
• Very good knowledge of German language is a must have.

SUMMARY

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

• Contact person for Austria and Switzerland.
• 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 CHC products where applicable per national regulations. Designate a back-up who replaces him/her when he/she is out of the office.
• 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 CHC 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 CHC 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.
• Act as Deputy CSH for a partner country.