Director, Pharmacovigilance Job at Recursion
Your work will change lives. Including your own.
Rather than make a prediction on one or two products or indications, what if you could build a biological map that supports dozens or hundreds of indications?
Every week at Recursion, we run 1.8 million+ experiments creating a library of more than one billion cellular images on the basis of that radically different approach to biotech. This is a revolutionary approach that we believe will reinvent drug discovery and development.
Recursion is the clinical-stage biotechnology company industrializing drug discovery by decoding biology. Recursion leverages sophisticated machine-learning algorithms to infer biological relationships. By commanding massive experimental scale and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
The Impact You'll Make
- Provide strategic planning, oversight, and management of PV operational and safety science activities to support the pharmacovigilance department's efforts to advance the Recursion pipeline.
- Oversee all outsourced PV activities, including but not limited to quality review of SAE reports to ensure accuracy of MedDRA coding, narrative, assessment, appropriate queries to clinical sites, and establishing and monitoring key quality and compliance metrics.
- Collaborate on all project teams requiring pharmacovigilance support
- Supervise the production and submission of required pharmacovigilance regulatory submissions (e.g., SUSARS, DSURs)
The Team You'll Join
Reporting to the Vice President, Drug Safety and Pharmacovigilance, you will be an essential member of the Recursion Development Team. The Development Team is an empowered, execution-minded group of drug development professionals responsible for bringing Recursion's ground-breaking science to the bedside. You will be joining the newly formed Pharmacovigilance team at Recursion, currently two in size (an operations Director and a safety physician) with growth on the horizon.
The Experience You'll Need
- Life Science Degree or Healthcare Professional (PharmD, PhD, MS, BS, RN, or RPh).
- 7+ years of experience in ICSR case processing, aggregate safety reporting, signal management, PV quality management systems, and PV compliance including PV inspections.
- Expert knowledge of global PV regulatory guidelines and legislation requirements, e.g., US Code of Federal Regulations, European Union regulations/Good Pharmacovigilance Practices, and ICH Guidelines.
- Ability to engage in a matrix environment to provide PV deliverables to cross-functional clinical development teams
- Experience in early phase product development
- Experience in vendor management
- Experience with the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate trials and products.
- Demonstrated understanding of MedDRA and WHO Drug Dictionary
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The Values That We Hope You Share:
- We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.
- We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
- We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover.
- Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.
- We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.
Recursion spends time and energy connecting every aspect of work to these values. They aren't static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.
More About Recursion
Central to our mission is the Recursion Operating System, or Recursion OS, that combines an advanced infrastructure layer to generate what we believe is one of the world's largest and fastest-growing proprietary biological and chemical datasets and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore foundational biology unconstrained by human bias and navigate to new biological insights which may accelerate our programs. We are a biotechnology company scaling more like a technology company. Recursion is proudly headquartered in Salt Lake City.
Learn more at www.recursion.com, or connect on Twitter and LinkedIn.
Recursion is an Equal Opportunity Employer that values diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
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