Associate Director Pharmacovigilance Operations

Intellia • Cambridge, MA

1d • Remote

About The Position

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.

Requirements

• 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 to meet deadlines.
• Strong analytical and problem-solving skills.
• Strong leadership skills.
• 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 or related software.
• Degree in life sciences required: (e.g., Nursing, Pharmacy)
• Minimum 5 years of progressive experience in Pharmacovigilance Operations within the pharmaceutical or biotechnology industry
• Direct BLA submission experience including establishing post-marketing pharmacovigilance processes and SOPs
• Proven track record in post-marketing pharmacovigilance management and oversight
• Direct experience managing global pharmacovigilance operations and regulatory reporting requirements
• Experience with safety database management and ICSR processing through third-party vendor
• Expert knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH, etc.)
• Strong understanding of MedDRA coding and WHODrug dictionaries
• Experience authoring SOPs and work instructions in a regulated environment
• Familiarity with safety database systems (e.g., Argus Safety, or similar platforms)

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)
• Parti cipate 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

Benefits

• 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.
• For more information about Intellia’s benefits, please click here .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level