Medical Director, Patient Safety and Pharmacovigilance

Apply for this position Please mention DailyRemote when applying
📅  Posted 13 days ago 📍 NULL 💵 Not specified
Before you apply - make sure the job is legit.

Attempting to apply for jobs might take you off this site to a different website not owned by us. Any consequence as a result for attempting to apply for jobs is strictly at your own risk and we assume no liability.

Job Description

Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem. We're looking for a Medical Director of Patient Safety and Pharmacovigilance to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?

What You'll Do

In this role reporting to the Head of Research Oncology, Clinical Research, you'll work with Flatiron’s research teams to provide clinical leadership and safety oversight, ensuring quality and translating research into insights that benefit cancer patients.

Your focus will be to apply your biopharmaceutical scientific, managerial and operational training and expertise to the tech-enabled clinical research products, services and trials that Flatiron offers. You will play the critical role in execution and growth of our patient safety and pharmacovigilance (PV) function to ensure the quality of safety oversight and analyses are in line with industry PV standards, 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:

  • Provide medical and scientific safety support to clinical trials, including:
    • Safety monitoring
    • Signal detection and evaluation
    • Protocol and Informed Consent Form (ICF) design
    • Safety endpoints in the Statistical Analysis Plan (SAP)
    • Set-up of safety analyses in prospective real world and clinical trial databases
  • Ensure compliance with all applicable US and foreign legal and regulatory requirements for adverse event reporting, safety management and pharmacovigilance for Flatiron Clinical Research, including:
    • Safety issue management
    • Establishment of and adherence to Safety Monitoring Plans
    • Assessment and oversight of activities for monitoring adverse event reports for potential safety related issues and provision of recommendations when issues are identified
  • Hold primary responsibility for safety oversight and compliance, including Contract Research Organization (CRO) management, as required
  • Review, update or write company SOPs related to Pharmacovigilance and safety reporting to ensure compliance with US and global regulatory guidelines
  • 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 prospective real world studies
  • Assist Clinical Data with MedDRA and WHO dictionary codes and and ensure quality and accuracy of study generated safety data 
  • 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 kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition you're a seasoned professional with at least 4-7 years of Drug Safety/Pharmacovigilance biopharmaceutical experience. You have experience and keen interest in working cross functionally with clinicians, clinical operations and data management professionals, regulatory experts, engineers and other technical experts to apply and adapt pharmacovigilance functions in the real-world setting. 

  • You are an M.D., Ph.D., PharmD or equivalent 
  • You have experience as a Senior Associate Director or Director of PV/Patient Safety for a bio-pharmaceutical/pharmaceutical company or CRO, or an equivalent role in a large pharmaceutical company in support of the therapeutic area/business unit
  • You have a thorough understanding of the cross functional drug development processes and context applicable to safety surveillance activities required.
  • Knowledge of MedDRA terminology and its application required
  • 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

Extra Credit

  • You have experience in clinical development
  • You have experience in oncology
  • You have experience with PV audit processes with active participation in Regulatory Authority Inspections

Where you’ll work 

In this remote position, you have the freedom to choose your preferred work location while aligning your working hours with your team's. For further details on our hybrid work approach and remote work type, please visit the how we work website.

Life at Flatiron 

At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer: 

  • Work/life autonomy via flexible work hours and flexible paid time off
  • Comprehensive compensation package
  • 401(k) contribution to help you reach your retirement planning goals
  • Financial health resources including 1:1 financial advice
  • Mental well-being tools and services 
  • Parental benefits and policies including family-building care and generous leave
  • Path to parenthood programs supporting fertility, adoption and surrogacy
  • Travel support for safe healthcare services
  • Lifestyle spending account for perks that make sense for you and your family

In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning through professional development programs and celebrate Diversity in the workplace