Senior Manager, Pharmacovigilance Operations

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

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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.