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 Italy. All CV's must be submitted in English language for the assessment.
Responsibilities:
Act as a Local Safety Officer and Medical Information Specialist in Italy (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 Requirements
Biologist, Pharmacist, Medical Doctor, or other life science degree
2-year experience in Pharmacovigilance
Fluent in English and Italian languages
Computer literacy (MS Office), experience with PV databases
Strong organizational and time management skills
Ability to work independently and in a team Benefits
Professional growth and career opportunities
International team and environment
Bonus based on annual performance
Personal accident and business trip insurance
Additional health insurance
Remote/home based
Rewarding referral policy
Workplace establishment allowance
Team building, global meetings
Biomapas is a regulatory affairs and pharmacovigilance services company that supports pharmaceutical, medical device, food supplement, and cosmetics clients. The company provides comprehensive regulatory compliance services including regulatory affairs support, pharmacovigilance operations, adverse event management, and regulatory intelligence. Biomapas works with an international team to manage client interactions with national authorities, maintain regulatory databases, and ensure data integrity and safety compliance across multiple product portfolios.
