BioSpace
Vice President, Drug Safety and Pharmacovigilance
BioSpace - Cambridge, Massachusetts, us, 02140
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Overview
Vice President, Drug Safety and Pharmacovigilance
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Vice President, Drug Safety and Pharmacovigilance
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BioSpace Vice President, Drug Safety and Pharmacovigilance
2 days ago Be among the first 25 applicants Join to apply for the
Vice President, Drug Safety and Pharmacovigilance
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BioSpace Get AI-powered advice on this job and more exclusive features. 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. Core Values and Mission Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver. We believe in curiosity, pushing boundaries, and developing innovative solutions to make a real difference for patients. We aim to go beyond treating symptoms, driven to cure and motivated for change. How You Will Achieve More With Intellia The Vice President of Drug Safety and Pharmacovigilance will lead the development and execution of the company's safety strategy across all stages of product development and commercialization. This executive role requires a dynamic leader capable of overseeing pharmacovigilance operations, safety surveillance, risk management, and ensuring regulatory compliance, while providing safety leadership across clinical development programs and post-marketing. Key Responsibilities
Develop and execute a comprehensive drug safety and pharmacovigilance strategy aligned with company objectives and regulatory requirements. Oversee safety signal detection, evaluation, and risk mitigation strategies for all products in the pipeline. Ensure compliance with global safety regulations, including FDA, EMA, and ICH guidelines. Build and lead a high-performing pharmacovigilance team, fostering a collaborative culture. Collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs to embed patient safety throughout the product lifecycle. Develop and maintain risk management and safety monitoring plans for clinical and marketed products. Provide medical oversight for safety activities, including review of safety reports and data. Serve as the primary contact for pharmacovigilance interactions with regulatory authorities and external partners, overseeing safety sections of regulatory filings. Qualifications
MD or equivalent with relevant clinical experience. Minimum of 15 years in pharmacovigilance and drug safety within biotech or pharma, with at least 5 years in leadership. Experience in gene editing or rare diseases is highly desirable. Strong understanding of global safety regulations and industry standards. Proven success in BLA and MAA regulatory submissions and product launches. Leadership skills in managing high-performing teams in a matrixed environment. Excellent communication skills for diverse audiences. Preferred Qualifications
Experience with safety data management systems. Knowledge of safety considerations specific to gene editing technologies. Experience in originating safety programs for first commercial biotech products. Ability to navigate safety aspects through late-stage development and commercialization. Covid-19 Vaccination Policy:
All employees are expected to follow applicable health regulations and are encouraged to be vaccinated. EEOC Statement:
Committed to diversity and equal opportunity, providing reasonable accommodations for disabilities.
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Join to apply for the
Vice President, Drug Safety and Pharmacovigilance
role at
BioSpace Vice President, Drug Safety and Pharmacovigilance
2 days ago Be among the first 25 applicants Join to apply for the
Vice President, Drug Safety and Pharmacovigilance
role at
BioSpace Get AI-powered advice on this job and more exclusive features. 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. Core Values and Mission Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver. We believe in curiosity, pushing boundaries, and developing innovative solutions to make a real difference for patients. We aim to go beyond treating symptoms, driven to cure and motivated for change. How You Will Achieve More With Intellia The Vice President of Drug Safety and Pharmacovigilance will lead the development and execution of the company's safety strategy across all stages of product development and commercialization. This executive role requires a dynamic leader capable of overseeing pharmacovigilance operations, safety surveillance, risk management, and ensuring regulatory compliance, while providing safety leadership across clinical development programs and post-marketing. Key Responsibilities
Develop and execute a comprehensive drug safety and pharmacovigilance strategy aligned with company objectives and regulatory requirements. Oversee safety signal detection, evaluation, and risk mitigation strategies for all products in the pipeline. Ensure compliance with global safety regulations, including FDA, EMA, and ICH guidelines. Build and lead a high-performing pharmacovigilance team, fostering a collaborative culture. Collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs to embed patient safety throughout the product lifecycle. Develop and maintain risk management and safety monitoring plans for clinical and marketed products. Provide medical oversight for safety activities, including review of safety reports and data. Serve as the primary contact for pharmacovigilance interactions with regulatory authorities and external partners, overseeing safety sections of regulatory filings. Qualifications
MD or equivalent with relevant clinical experience. Minimum of 15 years in pharmacovigilance and drug safety within biotech or pharma, with at least 5 years in leadership. Experience in gene editing or rare diseases is highly desirable. Strong understanding of global safety regulations and industry standards. Proven success in BLA and MAA regulatory submissions and product launches. Leadership skills in managing high-performing teams in a matrixed environment. Excellent communication skills for diverse audiences. Preferred Qualifications
Experience with safety data management systems. Knowledge of safety considerations specific to gene editing technologies. Experience in originating safety programs for first commercial biotech products. Ability to navigate safety aspects through late-stage development and commercialization. Covid-19 Vaccination Policy:
All employees are expected to follow applicable health regulations and are encouraged to be vaccinated. EEOC Statement:
Committed to diversity and equal opportunity, providing reasonable accommodations for disabilities.
#J-18808-Ljbffr