Safety Risk Management Scientist, Drug Safety & Pharmacovigilance

Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

Why JoinIntellia:

Our mission is to developcurativegenome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. Wearen’tconstrained by typical end rails, and wearen’tout to just “treat” people.We’reall in this for something more.We’redriven to cure and motivated for change. Just imagine the possibilities of what we can do together.

How you will Achieve More with Intellia:

We are excited to welcome this new member to our growing team and company. This role collaborates with the safety physician and clinical development team to the safety and benefit-risk evaluations for the assigned products. This role requires strong safety surveillance and risk management experience in early and late-stage clinical development settings. Experience with IND and or BLA submissions is a plus.

If you are a strong problem-solver, agile with detailed regulations and requirements for global safety surveillance & safety risk management and enjoy cross-functional partnerships, this is the role for you! As the Safety Risk Management Scientist, you will lead and work on various projects including but not limited to:

• Performs proactive safety monitoring and signal detection for assigned products and presents the findings to cross-functional team and safety governance

• Authors signal assessment report as part of signal detection process, develop safety monitoring plan and pharmacovigilance plan as required

• Authors safety risk management plan for products under clinical development and post-marketing

• Oversight on the activities related to the periodic reports preparation (DSUR) in collaboration with the assigned external vendor(s).

• Authors and/or reviews documents or sections of key documents as they relate to safety and safety monitoring (e.g.: protocols, protocol amendments, Investigator Brochures, Informed Consent Forms etc.)

• Authors and/or reviews section of key CRO documents as they relate to safety and safety monitoring (Safety Management Plan, Medical Monitoring Plan, SAE Reporting, Communications plan, etc.

• Contribute for the development of safety surveillance & risk management SOPs, templates

• Collaborate with PV Operation team and clinical study team on safety surveillance deliverables

• Participate in PV audit and inspections

About You:

You are an experienced safety surveillance and risk management scientist with a degree in life sciences (Pharmacy degree, Nursing degree or MS in health-related field) and 7+ years’ experience in safety surveillance and risk management (experience in oncology or immunology therapeutic areas preferred). You have in depth understanding on FDA and EU-GVP guidance on safety signal management, periodic report development and safety risk management. You are detail-oriented and have strong written, organizational and communication skills. You are intrigued by the new challenges to pharmacovigilance that accompanies novel gene editing therapies. Your prior experience with gene therapy products or biologics and advanced trainings in epidemiology will be plus. On a product/program team, you work collectively with all relevant functions for DSPV including medical, clinical operations, data management, biostatics, regulatory, quality and manufacturing.

Meet your future team:

Intellia strives to form an experienced, patient-focused drug safety & pharmacovigilance (DSPV) function. The present team is comprised of small team of experienced PV professionals including Safety physician, safety scientist, PV operations lead and the functional head. Plans are in place to build a team of knowledgeable and conscientious pharmacovigilance professionals to support our growing portfolio. This role has the ability to work remotely.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.