Biomapas
Healthcare
PharmacovigilanceSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Pharmacovigilance Specialist at Biomapas. Skills: Pharmacovigilance. Act as a Local Safety Officer and Medical Information Specialist in Romania (nomination as per local requirements). Communicate with Health Authorities”
Industry & Context.
What They're Looking For.
Must Have
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, organizational and time management skills, Ability to work independently and in a team
What You'll Do.
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
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
How You'll Work.
Team & Collaboration
Interact, exchange relevant safety and pharmacovigilance information; Participate in inspection and/or audits; International team and environment
Communication Scope
Communicate with Health Authorities; exchange relevant safety and pharmacovigilance information; Communicate of safety information, product quality complaints and medical device incidents; Receive and handle medical information enquiries from patients and health care professionals
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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