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Biomapas

Pharmacovigilance Specialist Romania

Posted a month ago
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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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