Director, Safety and Pharmacovigilance

Location
Salt Lake City, Utah, United States
Posted
Jun 07, 2021
Ref
3127786
Required Education
Masters Degree/MBA
Position Type
Full time

Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering to radically improve the lives of patients and industrialize drug discovery. Our team is working to solve some of the hardest, most meaningful problems facing human health today. Come join us in our mission to decode biology to radically improve lives, while doing the most impactful work of your life.

***Flexible work arrangements for those who are unable to relocate***

The Impact You’ll Make

Lead and provide direction for all product safety and pharmacovigilance activities, including the detection and analysis of safety issues in compliance with global pharmacovigilance and regulatory requirements. You will oversee the medical safety assessments, risk management strategies, reference safety information (RSI), and regulatory compliance reporting for Recursion. 

  • Lead safety surveillance activities, adverse event assessment and reporting and providing pharmacovigilance scientific support and guidance 
  • Guide team on defining the RSI for each product; update RSI as needed for key clinical and regulatory documents 
  • Oversee safety governance including safety data review and signal detection, managing adverse event reporting, and mitigate plans for clinical stage programs
  • Ensure compliance with all applicable laws and regulations across all regulatory reporting requirements 
  • Develop and implement safety surveillance strategies, and policies and procedures for all investigational products
  • Implement and manage pharmacovigilance and safety vendors across all programs
  • Serve as the primary PV point of contact for the organization

The Team You’ll Join 

Reporting to the Chief Medical Officer, the Director, Safety Pharmacovigilance 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 translating Recursion's innovative science to patients through clinical development activities.

The Experience You’ll Need

  • Minimum 10 years Drug Safety/Pharmacovigilance experience
  • MD or equivalent, PharmD, or advanced degree in nursing
  • Experience with clinical trials and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials
  • Strong knowledge and understanding of pharmacovigilance regulations and thorough understanding of FDA and EU regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance
  • Experience in signal detection and risk management, including interactions with regulatory authorities
  • Excellent written and verbal communication skills and ability to work collaboratively as a part of a team

The Benefits/Perks You’ll Enjoy

  • 100% Coverage of health, vision, and dental insurance premiums 
  • 401(k) with generous matching (immediate vesting)
  • Stock option, restricted stock unit (RSUs) and employee stock purchase plan (ESPP) programs**
  • Two one-week paid company closures (summer and winter) 
  • Flexible vacation/sick leave
  • Generous paid parental leave (including adoptive)
  • Onsite daycare facility**
  • Commuter benefit and vehicle parking to ease your commute** 
  • Complimentary chef-prepared lunches and well-stocked snack bars** 
  • Monthly fitness/wellness stipend 
  • One-of-a-kind 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers, and bike parking**

*Subject to change for remote-based employees during the COVID-19 pandemic

**United States based employees

More About Us 

Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science, and engineering, with the goal of radically improving the lives of patients and industrializing drug discovery. 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.