Associate Director, Pharmacovigilance Quality
Bluebird Bio, Remote
integrated product platforms with broad therapeutic potential
ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
The Pharmacovigilance flock is all about ensuring patient safety and working collaboratively together and cross-functionally to bring safe and effective medicines to our patients. Come work with a close knit group of birds that love their jobs, and work extremely hard all the while having fun at the same time!
HOW YOU’LL FLY
As an Associate Director of PV Quality bird reporting to the Director of PV Quality, you'll help to bring more patients their bluebird days by:
- Supporting R&D Quality Assurance (QA) by engaging and providing support of the R&D QA pharmacovigilance/clinical safety audit plan, compliance, audit and inspection activities, inspection readiness and other cross functional initiatives
- Monitoring PV non-conformance trends and communicate this information to management with proposed remediation actions
- Participating and/or leading activities related to the update and maintenance of the Pharmacovigilance System Master File (PSMF)
- Participating in the oversight of all PV service providers, including the tracking and trending of key performance indicators (KPIs) and key quality indicators (KQIs)
- Participating in the process review of content for social media/websites where there is a potential for adverse event information to be collected
- Participating in the pharmacovigilance agreement (PVA) process, including the generation, maintenance, and periodic review of PVAs and associated templates
- Participating in the development, delivery, implementation, maintenance, and tracking of the global PV training strategy (training matrix, processes, metrics, effectiveness verifications, process improvements) as well as process improvements including authoring and updating controlled procedures, and assist in the management of all PV controlled procedures, training, CAPAs, and QC system for applicable PV documents
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Have at least 5 years experience in pharmacovigilance and/or pharmacovigilance quality
- Have Health Authority inspection experience, including inspection readiness and CAPA management
- Have experience with the pharmacovigilance system master file (PSMF)
- Have effective communication, time management, project management, and problem solving skills
- Thrive in a fast-paced environment while juggling multiple tasks
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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