Pharmacovigilance Specialist Romania

Join our global Pharmacovigilance team as a Pharmacovigilance Specialist in Romania.

Pharmacovigilance Specialist is responsible for assuring compliance with local and regional Quality Management System and interact, exchange relevant safety and pharmacovigilance information.

Position is remote, home-based in Romania. All CV's must be submitted in English language for the assessment.

Responsibilities:

• Act as a Local Safety Officer and Medical Information Specialist in Romania (nomination as per local requirements)
• Communicate with Health Authorities
• Ensure compliance with applicable local guidelines and regulations
• Collect, process, and communicate of safety information, product quality complaints and medical device incidents
• Maintain and establish quality standards for local pharmacovigilance activities
• Ensure weekly monitoring of local literature review
• Participate in inspection and/or audits
• Ensure the survey and monitoring of national pharmacovigilance regulations
• Receive and handle medical information enquiries from patients and health care professionals

• Biologist, Pharmacist, Medical Doctor, or other life science degree
• 2-year experience in Pharmacovigilance
• Fluent in English and Romanian languages
• Computer literacy (MS Office), experience with PV databases
• Strong organizational and time management skills
• Ability to work independently and in a team