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Intellia Therapeutics, Inc. logo
Intellia Therapeutics, Inc.

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.

Director, Safety Risk Management Scientist

RiskRiskFull TimeRemoteLeadTeam 501-1,000

Location

United States

Posted

10 days ago

Salary

$219.6K - $268.4K / year

Seniority

Lead

No structured requirement data.

Job Description

Director, Safety Risk Management Scientist

Intellia Therapeutics, Inc.

Role Description 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. - 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. Qualifications - 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). - Advanced degree in epidemiology (desired). - At least 10 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. Benefits - The base salary for this position is expected to range between $219,606.00 - $268,408.00 USD per year. - 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. Company Description 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.

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