🕒 12 days ago
Delivers operational pharmacovigilance work for assigned projects, including literature screening, adverse event case processing and reporting, safety alert follow-up, and coordination with project leads.
Pharmacovigilance Specialist Romania
🕒 27 days ago
PharmacovigilanceSafety Information ProcessingMedical InformationRegulatory Compliance
📜 Description
- Communicate with health authorities and monitor national pharmacovigilance regulations
- Maintain quality standards and ensure compliance with local guidelines and regulations
- Monitor local literature weekly and participate in inspections or audits
🛠️ 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
- Act as Local Safety Officer and Medical Information Specialist in Romania
- Collect, process, and communicate safety information, product quality complaints, and medical device incidents
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
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