Pharmacovigilance Specialist - Remote

1w1 week ago

Biomapas

RO · Full-time · €24,000 – €42,000

About this role

Join our global Pharmacovigilance team as a Pharmacovigilance Specialist. Assure compliance with local and regional Quality Management System. Interact and exchange relevant safety and pharmacovigilance information while working remotely from home in Romania.

Act as Local Safety Officer and Medical Information Specialist per local requirements. Communicate with Health Authorities and ensure compliance with applicable local guidelines and regulations. Collect, process, and communicate 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 and participate in inspections or audits. Receive and handle medical information enquiries from patients and health care professionals.

Work in an international team and environment with professional growth opportunities. Enjoy bonus based on annual performance and team building activities. All CVs must be submitted in English for assessment.

Requirements

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

Responsibilities

Act as 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 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 inspections and/or audits
Ensure the survey and monitoring of national pharmacovigilance regulations
Receive and handle medical information enquiries from patients and health care professionals