Associate Director Pharmacovigilance Operations

Associate Director Pharmacovigilance Operations page is loaded## Associate Director Pharmacovigilance Operations locations:
Cambridge, MAtime type:
Full time posted on:
Posted Yesterday job requisition :
R1237

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  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 want all of our 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.

Intellia Therapeutics is seeking an experienced Associate Director of Pharmacovigilance Operations to join our growing Patient Safety team. 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. Reporting directly to the Senior Director of PV Operation, this role will be instrumental in establishing and managing post-marketing pharmacovigilance activities as we transition our innovative genetic medicine programs from clinical development to commercialization.

The successful candidate will provide strategic and operational leadership in global pharmacovigilance operations, with a focus on biologics and gene editing therapies.
** Duties/Responsibilities
*** Collaborate with PV Ops Sr. Director and provide support on alliance management related to safety reporting (egg., safety data exchange agreements, cross-reporting).
* Provide functional support for the management of Intellia's post-marketing safety database through our pharmacovigilance vendor, ensuring data integrity, quality, and compliance
* Author, review, and maintain Standard Operating Procedures (SOPs) and work instructions for pharmacovigilance operations activities including those related to post-marketing
* Ensure all pharmacovigilance operations activities comply with global regulations, good pharmacovigilance practices and international regulatory requirements
* Support regulatory inspections and audits related to pharmacovigilance operations
* Establish and maintain post-marketing pharmacovigilance processes and systems in preparation for and following BLA approval
* Support the development and execution of the post-marketing pharmacovigilance strategy for biologics and biosimilar products
* Lead post-marketing pharmacovigilance initiation activities
* Partner with Regulatory Affairs, Medical Affairs, Quality, and other cross-functional groups to ensure alignment on post-marketing activities roles and responsibilities (e.g., product complaints, call center management, adverse event reporting, submission requirements)
* Oversee and manage individual case safety report (ICSR) case processing through the PV vendor, ensuring timely and accurate reporting to regulatory authorities worldwide to include aggregate reporting activities (e.g., PADER/PSUR/PBRER)
* Participate in cross-functional safety review meetings and provide pharmacovigilance operations expertise
* Perform other pharmacovigilance operational activities as assigned by the Senior Director of PV Operations
* Mentor and provide guidance to junior staff members on pharmacovigilance operations best practices
** Supervisory Responsibilities
** N/A
** Requirements
* *** Skills/Abilities
*** Excellent verbal and written communication skills.
* Exceptional cross-functional collaboration and communication skills
* Excellent organizational skills and attention to detail.
* Excellent time management skills with a proven ability…