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
Requirements
- 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
Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance
- Flexible working hours
- Team building, global meetings, B active events
Top Skills
What We Do
Biomapas is a functional and full outsourcing solution provider to the global life science industry.
As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle.
Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success.
We keep our promises. Always.
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