Associate Director, Safety Scientist

Intellia Therapeutics, Inc.•Cambridge, MA

7d•Remote

About The Position

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 want all of our 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. Experienced Safety Surveillance and Risk Management Scientist with a degree in life sciences (Pharmacy degree, Nursing degree or master’s degree in health-related field) and 10+ years’ experience in safety surveillance and safety risk management. Have an in depth understanding on FDA and EU-GVP guidance on safety signal management, periodic report development, safety risk management and benefit-risk assessment. Detail-oriented and have strong written, organizational and communication skills. Will work collectively with all relevant functions for DSPV including R&D medicine, clinical operations, data management, biostatics, regulatory, quality, manufacturing and medical affairs.

Requirements

Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills.
Excellent sales and customer service skills.
Excellent organizational skills and attention to detail.
Excellent time management skills with a proven ability to meet deadlines.
Strong analytical and problem-solving skills.
Proficient with Microsoft Office Suite or related software.
Degree in life science (pharmacy , nursing or MS in health related field)
At least 5 years of experience from pharmaceutical/biotech companies predominantly in safety surveillance and safety risk management.
Prolonged periods of sitting at a desk and working on a computer

Nice To Haves

Advanced degree in epidemiology (desired)

Responsibilities

Performs proactive safety monitoring and signal detection for assigned products and presents the findings to cross-functional team and safety governance meetings.
Authors signal assessment report as part of signal detection process, develop safety monitoring plan and pharmacovigilance plan as required.
Manages cross-functional safety management team for the assigned product(s).
Authors safety risk management plan for products under clinical development and post-marketing.
Authors safety sections/modules for BLA/MAA submission dossier (SCS, ISS, Clinical overview).
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 to the development and revision of safety surveillance & risk management SOPs, template.
Collaborate with PV Operation team on medical review of ICSRs and clinical study team on safety surveillance deliverables for the assigned product.
Participate in PV audit and inspections.
Participate in PV audit and inspections