What are the responsibilities and job description for the Senior Manager, Pharmacovigilance Operations position at Intellia Therapeutics?

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.

As a member of the Drug Safety & Pharmacovigilance (DSPV) organization, the incumbent will provide Sponsor Medical Review of ICSRs processed by the Pharmacovigilance (PV) vendor. Provide functional support to the management of Intellia Safety database through a PV vendor, manage individual case safety report (ICSR) case processing through the PV vendor, other PV operational activities assigned by the Sr. Director of PV Operations. In this role you will work closely with the Intellia DSPV team, Clinical / Development Operations team, R&D Medical team, Regulatory affairs team, Quality organization and other cross-functional teams as applicable for clinical development as well post-marketing ICSR case processing.

Duties / Responsibilities

Manage and perform Intellia Sponsor Medical Review of all ICSRs entered in the safety database including but not limited to (75% of working hours) :

Initial / follow-up causality assessments, collaboration with DSPV Medical Lead(s) during case review and drafting of analysis of similar events (AOSE’s) of applicable cases.

Manage day to day activities associated with ICSR case processing (sponsor medical review, regulatory reporting, reconciliations etc.).

Assist with managing PV vendor that hosts and perform ICSR case processing.

Authors / collaborates / reviews sections of key PV CRO documents as they relate to safety database and case processing (Safety Management Plan, Medical Monitoring Plan, SAE Reporting, Communications plan, etc.).

Collaborate with PV vendor, clinical studies vendor(s) and regulatory operations to ensure quality and compliance for safety reporting (e.g., KPI).

Collaborate with PV Ops Sr. Director and support on alliance management related to safety (e.g., safety data exchange agreements, cross-reporting).

Contribute to the safety case processing SOPs, forms etc.

Liaise with cross-functional teams for timely communication / dissemination of PV operations deliverables.

Represent DSPV in clinical study team meetings.

Support GCP / GVP audits and inspections.

Support DSPV contributions for audit and inspections.

Assist with PV operational activities assigned by the Sr. Director of PV Ops.

Performs other related duties as assigned.

Supervisory Responsibilities

N / A

Requirements

Skills / Abilities

Experienced Pharmacovigilance professional with degree in life sciences (Nursing, Pharmacy) and 5 years of experience in PV operations in clinical development and / or post-marketing including :

ICSR case processing and medical review

PV vendor management

Alliance management and clinical trial operations.

Prior clinical experience from direct patient care as a nurse / pharmacist

Knowledge and hands-on experience of the good pharmacovigilance practices and international regulatory requirements such as EMA / FDA / ICH guidelines Strong project management

Prior experience with gene therapy products or biologics, post-marketing case processing is advantageous.

Excellent verbal and written communication skills.

Excellent organizational skills and attention to detail.

Strong project management skills.

Excellent time management skills with a proven ability to meet deadlines.

Ability to prioritize tasks and to delegate them when appropriate.

Ability to function well in a high-paced and at times stressful environment.

Proficient with Microsoft Office Suite, Argus safety database (or similar database).

Education / Certifications

A degree in life sciences (e.g., Nursing, Pharmacy)

Experience

Experienced Pharmacovigilance professional with degree in life sciences (Nursing, Pharmacy) and 5 years of experience in PV operations in clinical development and / or post-marketing including :

ICSR case processing and medical review

PV vendor management

Alliance management and clinical trial operations.

Prior clinical experience from direct patient care as a nurse / pharmacist

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.

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Senior Manager, Pharmacovigilance Operations

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