Biomapas
Healthcare
PharmacovigilanceSpecialistItaly
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Pharmacovigilance Specialist Italy at Biomapas. Skills: Pharmacovigilance, Regulatory compliance, Safety information. Act as Local Safety Officer. Act as Medical Information Specialist”
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 Italian 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 Local Safety Officer
Act as Medical Information Specialist
Communicate with Health Authorities
Ensure compliance with local guidelines
Ensure compliance with local regulations
Collect safety information
Process safety information
Communicate safety information
Collect product quality complaints
Process product quality complaints
Communicate product quality complaints
Collect medical device incidents
Process medical device incidents
Communicate medical device incidents
Maintain quality standards
Establish quality standards
Ensure weekly literature review monitoring
Participate in inspections
Participate in audits
Ensure survey of national regulations
Ensure monitoring of national regulations
Receive medical information enquiries
Handle medical information enquiries
How You'll Work.
Team & Collaboration
International team; Global environment
Communication Scope
Safety information communication
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 Italy.**_All CV's must be submitted in_ _**English language**_ _for the assessment._ ### Responsibilities: * Act as a Local Safety Officer and Medical Information Specialist in Italy (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 Italian 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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