Pharmacovigilance Specialist (Remote, Romania)
Job Description
**Pharmacovigilance Specialist** is responsible for ensuring compliance with local and regional Quality Management Systems and exchanging relevant safety and pharmacovigilance information.
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 safety information, product quality complaints, and medical device incidents
- Maintain and establish quality standards for local pharmacovigilance activities
- Ensure weekly monitoring of local literature reviews
- Participate in inspections and/or audits
- Ensure the survey and monitoring of national pharmacovigilance regulations
- Receive and handle medical information inquiries from patients and healthcare professionals
Requirements:
- Biologist, Pharmacist, Medical Doctor, or another life science degree
- 2-year experience in Pharmacovigilance
- Fluent in English and Romanian languages
- Computer literacy (MS Office), experience with pharmacovigilance (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
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