Product Life Group is looking for Vigilance Specialist/ Local Safety Officer to join our dynamic PV team.
Responsibilities Act as local safety officer/ local QPPV / local PV representative for MAH products in the territory. Main contact and communication for health authority and the MAH. Nomination of the details with the local health authority Participation in audits Revison of PhV contracts Monthly reconciliations with partners Weekly or monthly (depending on the frequency of publication)surveillance of local journals Monthly surveillance of local Health Authority website for identification of safety related data. Answering calls from the patients/consumer/partners PV mailbox management Local case management activities, including translation and follow-up of PV cases in local language
Education & Experience Science degree, Life sciences degree (Nurse, dentist, Pharmacist or medical degree), chemistry degree, or chemical engineering degree 0-4 years of experience in Pharmacovigilance/drug safety Local PV knowledge in the country EU GVP and ICH/GCP understanding Experience in case management or medical information and literature or medical writing in English Knowledge of the relevant local regulation and EU GVP
Skills Hungarian, any other European language would be desirable Agility and analytical Proficiency in professional and technical Organization, initiative, anticipation and adaptability Good interpersonal skills, team player and excellent communication skills Ability to attend customer facing teams & F2F meetings