We're looking for a Head of Pharmacovigilance (PV) and Risk Management (RM) to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here's what you need to know about the role, our team, and why Flatiron Health is the right next step in your career.
What You'll Do
In this role reporting to the Chief Medical Officer, you'll work with Flatiron’s research teams to provide clinical and research leadership, ensuring quality and translating real-world data into insights that benefit cancer patients.
Your focus will be to build from the “ground up” our real world pharmacovigilance organization, applying your biopharmaceutical scientific, managerial and operational training and expertise to the real-world setting in which Flatiron operates. You will play the critical leadership role in helping to shape and grow our pharmacovigilance function to ensure the quality of safety oversight and analyses are in line with industry PV standards and evolving PV regulations and legislation. You will be seen as a thought leader, scientist, collaborator and teacher to cross-functional internal teams as well as to our partners. In addition, you’ll:
- Lead pharmacovigilance and risk management activities across three primary domains:
- Prospective "end to end" clinical trials and subject matter expertise (SME) to support technology solutions and innovations in clinical research
- Oversight of safety notification and reporting obligations to Sponsors working with retrospective data
- Creation of new research data products addressing relevant safety, PV and risk management needs in collaboration with Flatiron product teams
- Hold primary responsibility for safety oversight and compliance, including Contract Research Organization (CRO) management, as required
- Build and manage a high-performing pharmacovigilance function by setting clear expectations and providing hands-on management and leadership, promoting collaboration across multiple teams
- Provide internal and external guidance through the development of new trainings, processes and products as it relates to the management and interpretation of safety data in a real-world setting
- Provide strategic oversight and accountability for safety sections of all client-facing and regulatory-facing documents
- Develop the Pharmacovigilance budget and long-term forecast, creating timeline management systems and processes to ensure achievement of key deliverables
- Monitor PV literature for trends in real world event monitoring, characterization and management recommendations
- Collaborate cross-functionally and with key internal and external stakeholders, including regulatory agencies, alliance partners, Key Opinion Leaders (KOLs), and senior management
Who You Are
You're a seasoned Pharmacovigilance professional with at least 10 years of experience working in a PV leadership role within the biopharmaceutical industry. You have experience and keen interest in working cross functionally with clinicians, quantitative scientists (i.e. biostatisticians, epidemiologists, data scientists), clinical operations and data management professionals, engineers and other technical experts to apply and adapt pharmacovigilance functions in the real-world setting. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You’re a kind, passionate and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.
- You are an M.D., Ph.D., PharmD or equivalent
- You have experience as the Head of Drug Safety/Patient Safety/ Product Safety and Pharmacovigilance for a bio-pharmaceutical/pharmaceutical company or CRO, or an equivalent role in a large pharmaceutical company in support of the oncology therapeutic area/business unit
- You have experience assessing real-world safety data
- You have had direct responsibility and accountability for global health authority interactions re: issues pertaining to marketing authorization applications, product labeling negotiations, post marketing requirements/commitment negotiations and execution, and marketed product safety surveillance
- You possess an understanding of current global safety regulatory reporting requirements for investigational and marketed products
- You have outstanding communication and presentation skills
- You have experience mentoring all levels of staff to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters retention
- You have experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics
- You are effective at driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams
- You have the ability to manage multiple projects simultaneously in a fast-paced environment
- You can easily explain scientific and clinical safety concepts to a non-medical, highly sophisticated audience, and have a willingness to teach and learn
- You have public company experience
- You have worked with rare diseases
Why You Should Join Our Team
A career at Flatiron is a chance to work with everyone involved in the future of cancer care and research—all under one roof. Researchers, data scientists, designers, clinicians, technologists and many more all work together to improve cancer care and accelerate research.
At Flatiron, we strive to build and maintain an environment where employees from all backgrounds are valued, respected and have the opportunity to succeed. You'll also find a culture of continuous learning, broad and inclusive employee support offerings, and a commitment to supporting our team members in all aspects of their lives—at home, at work and everywhere in between. We offer:
- Flatiron University training curriculum which includes presentation skills, meeting mastery, coding languages and more
- Career coaching opportunities
- Hackathons for all employees (not just our engineers!)
- Professional development benefit for attending conferences, industry events and external courses
- Work/life autonomy via flexible work hours and flexible paid time off
- Generous parental leave (16 weeks for either parent)
- Back-up child care
- Employee Resource Groups (ERGs) that encourage our employees to share their unique experiences and perspectives
- Flatiron-sponsored fitness classes
Flatiron Health is proud to be an Equal Employment Opportunity employer.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.