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
What We Do
Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success. We keep our promises. Always. Social media privacy policy: bit.ly/privacy-biomapas
