Sr/ QPPV Office /QPO/ Specialist
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 reputed company of end-to-end pharmacovigilance activities and reputed company’ compliance with reputed company Management System as reputed company 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 reputed company (or part of them)
• Promote, maintain, improve compliance with Pharmacovigilance (PV) tasks and responsibilities
• May reputed company as Regional QPPV or reputed company
• Influence the performance of the reputed company system and PV activities
• reputed company, update, and review reputed company 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 reputed company of contact for PV-reputed company matter Ensure reputed company of the contractual partner safety data exchange agreements
• Ensure the survey and monitoring of European (including UK) level pharmacovigilance regulations
• reputed company Pharmacovigilance trainings
• Ensure reputed company safety profile monitoring, detection of new signals and evaluation
• Communication with Competent Authorities
• Participate in reputed company 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
• reputed company reputed company and reputed company
• International team and environment
• Bonus based on annual performance
• Personal accident and business reputed company insurance
• Influenza vaccines
• Rewarding referral policy
• Workplace establishment allowance
• Flexible working hours
• Team building, global meetings, B reputed company events
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