Drug Safety and Pharmacovigilance (DSPV) Co-op - Intellia Therapeutics
Cambridge, MA
About the Job
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.
How you will Achieve More with Intellia:
As a motivated Co-op, you will join our drug safety and pharmacovigilance (DSPV) team, where you will participate in various activities under the supervision of experienced pharmacovigilance professionals to gain an overarching understanding and experience on fundamentals of drug safety and pharmacovigilance for gene editing products including but not limited to :
a) PV Operations (safety case processing, safety database and vendor management
b) Safety Surveillance & Safety Risk Management ( safety signal management, safety risk management plans, periodic safety update reports).
Your main responsibilities will include:
Assist in day-to-day interaction with Intellia vendors as related to case processing.
Assist in ensuring that safety reports are triaged, scheduled, processed, and reported accordingly per global requirements and Intellia SOPs
Participate in regular safety data reviews for safety signal detection and attend safety management team meetings.
Assist in the preparation of development safety update reports (DSURs) and attend DSUR meetings.
Assist in the updates of development risk management plans (DRMPs) and attend DRMP meetings.
About You:
Are you a college student with a strong interest in learning about Drug Safety and Pharmacovigilance? Have you taken some courses related to epidemiology, pharmacovigilance, project management? Do you want to know more of the roles and responsibilities of the DSPV function leading to a potential career in the field? Do you describe yourself as a great collaborator, who wants to leverage what you have learned in class and apply it within mentored and structured setting? If so, we want you! For this Co-op role, we are looking for someone who is:
Curious about the role of PV operations related to the management of Drug Safety adverse events and applicable regulatory submissions.
Desire to understand safety surveillance, signal detection and safety risk management and the role of a Safety Risk Management Safety Scientists.
A “can do” attitude with the ability to work in an independently with guidance from a DSPV mentor.
Meet your future TEAM:
The DSPV team is a small but integral part of Intellia’s Clinical Development Organization. We are motivated to make an impact on patient safety through careful review of safety data, collaboration with cross-functional teams and compliance with all regulations.
Your future hiring manager is the Senior Director of PV Operations. He has 12+ years’ experience in the field of PV Operations. Additionally, you will collaborate with or Safety Risk Management Scientists and Safety Physicians to get exposure on safety surveillance and safety risk management activities for novel gene editing products.
The team is currently working mostly offsite.
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.
