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.

Duties/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

Requirements

Skills/Abilities

• 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.

Education / Certifications

• Degree in life science (pharmacy , nursing or MS in health related field)
• Advanced degree in epidemiology (desired)

Experience

• At least 5 years of experience from pharmaceutical/biotech companies predominantly in safety surveillance and safety risk management.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer

#LI-Remote

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

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.

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please click here.