Vigilance Officer (Romania)

About The Job  Product life Group is seeking a Local Pharmacovigilance Officer, to join our growing life sciences company who will have the ownership of all local PV activities. This position will be based in Romania and will be initially for a 2 year fixed term contract with the possibility of extension and/or permanent contract
Responsibilities  The Pharmacovigilance officer will take ownership of and be responsible for:
PV reports
Local calls and reply (as applicable)
Local regulatory intelligence
Local literature support
Coordination with the client
Participation in audits and inspections as required
Ensuring understanding of client needs, conventions
Training other team members of the client
Skills And Experiences   Degree in a Life Science relevant discipline, ideally Pharmacy
Minimum 1-2 years experience working for service providers or pharmaceutical company in Pharmacovigilance department
Local safety guidelines in Romania
Pharmaceutical background strong understanding of GVP, local regulations and regulatory requirements related to drug/cosmetic safety
Knowledge of pharmacovigilance principles, adverse event reporting
Experience in EU Pharmacovigilance
Client communications
Safety Database experience
Proficiency in Romanian language is required
Additional Skills   Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team
Ability to deliver constructive feedback

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