Job description
Join our global Pharmacovigilance team as a Sr. QPPV Office (QPO) Specialist.
Sr. QPPV Office (QPO) Specialist is responsible for the development of pharmacovigilance systems, and the oversight of end-to-end pharmacovigilance activities and projects’ compliance with Quality Management System as well as the reporting and exchanging of safety and pharmacovigilance information for medicinal products.
Position is in any EU country.
Responsibilities:
Manage full Pharmacovigilance systems and projects (or part of them)
Promote, maintain, improve compliance with Pharmacovigilance (PV) tasks and responsibilities
May act as Regional QPPV or deputy
Influence the performance of the quality system and PV activities
Develop, update, and review standard operating procedures for global pharmacovigilance processes, and implement changes to fulfill requirements
Supervise, prepare and submit PSURs, Risk Management Plans and risk minimization activities
Be the primary point of contact for PV-related matter Ensure oversight of the contractual partner safety data exchange agreements
Ensure the survey and monitoring of European (including UK) level pharmacovigilance regulations
Provide Pharmacovigilance trainings
Ensure continuous safety profile monitoring, detection of new signals and evaluation
Communication with Competent Authorities
Participate in related inspection and/or audits
University degree in Life Science field
At least 4 years of experience in pharmacovigilance roles, including in-depth, demonstrated experience in most areas pertaining to pharmacovigilance, and expert knowledge of pharmacovigilance legislation
Experience in regional QPPV role and risk minimization activities will be considered as an asset
Experience in Pharmacovigilance Medical writing
Strong computer literacy with intensive experience with safety databases
Ability to interpret and apply global drug safety regulations
Fluent English language
Good knowledge of medical terminology
Attention to detail, time-management and problem-solving skills
Proficient knowledge in MS Office
Professional growth and career opportunities
Supportive work environment
Additional benefits (bonus system, additional health insurance and etc.)
International team
Remote work
