#WeAreAzierta, part of the #QbDGroup , a pharmaceutical consulting firm, partner of life sciences companies. We globally support our clients in the development, transformation and integral management of the life cycle of their products and services, resulting in a premium service of high quality consulting, always for the benefit of patients and consumers worldwide.
We are looking for a Drug Safety Officer with a veterinary background and at least 3 years of experience in the field. A master in the pharma industry will be positively valued.
What do we expect from you as a Drug Safety Officer? Check and control compliance with the deadlines and work methodology established in the pharmacovigilance agreement/contract between Azierta and clients.
Perform quality control of the different Pharmacovigilance activities: case management, reconciliations, Authority information searches, medical information management.
Preparation and review of reports and signal detection analysis .
Develop and review Pharmacovigilance System Master Files (PSMF).
Develop and review customer pharmacovigilance standard operating procedures (SOPs/WI).
Review Azierta's SOPs to verify that they are adapted to customer requirements where applicable.
Develop and review pharmacovigilance agreements between Azierta and customers.
Develop and review PV agreements (SDEAs) with third parties on behalf of clients.
Support in Pharmacovigilance inspections and audits.
Development, monitoring and evaluation of the CAPA plan applicable to projects.
Review and manage Quality activities (deviations / CAPAs) related to customer Pharmacovigilance activities.
Project manager for different clients, controlling all delegated Pharmacovigilance activities (internal and external).
Who are we looking for? You preferably hold a Master degree in the pharmaceutical industry .
You have a minimum of 3 years' experience in a drug safety officer position with a background in veterinary drugs.
A true QbD'er can be recognized by the following qualities:
Resilient : Your strong and positive attitude helps you overcome any challenge.
Hungry for knowledge: You are always open to learning.
No non-sense mentality: you can be straightforward in a respectful way.
Innovative : You are constantly looking for new and better solutions.
(Not too) serious: your job is serious, but you don't take yourself too seriously.
What's in it for you? QbD Group offers you an attractive and competitive salary package , that will be tailored to individual needs, considering legal requirements and local laws and regulations.
Join us to build a sustainable career , where job security is ensured, and lasting, meaningful connections are formed.
As we're a knowledge-based company , you're guaranteed to embark on a continuous journey of learning and development.
Be part of our global success story. As an award-winning company , we value everyone's contribution and celebrate achievements together.
Our promise to you:
As an ambitious and pioneering company , we want to offer you the best possible environment to thrive within the life sciences.
Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
In short … We stand for? JPEG : J oy in P artnership, going for the E xtra mile to G et things done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
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