Vigilance Officer (Romania)

About The Job

Productlife 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
• Microsoft package

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
• Emotional intelligence
• Adaptability Analytical skills
• Strong organisation skills