Overview
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
Full job description
Full Job Description
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
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
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
Qualifications And Requirements
Mid-Senior level
Requirements & qualifications
Mid-Senior level
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Verification notes
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