Associate Director, Pharmacovigilance Operations

CRISPR Therapeutics AG • South Boston, MA

68d • Remote

About The Position

CRISPR Therapeutics is searching for an Associate Director, Pharmacovigilance Operations to manage global case processing, safety reporting, and vendor oversight for our clinical programs. The Associate Director, Pharmacovigilance (PV) Operations will contribute to a full range of pharmacovigilance activities: overseeing the management of individual case safety reports (ICSRs), supporting PV vendors, and safety governance. The successful candidate will work cross functionally to ensure robust and compliant safety operations.

Requirements

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science.
• 12+ Years of relevant experience with a bachelor's degree
• 10+ Years of relevant experience with an advanced degree
• Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
• Knowledge and understanding of global pharmacovigilance regulatory requirements and general regulatory expectations
• Advanced knowledge of common data processing software and safety database systems
• Demonstrated knowledge of pharmacovigilance and risk management including development
• Excellent written and verbal communication skills, with ability to collaborate cross-functionally

Nice To Haves

• Advanced degree in a scientific field or healthcare professional degree (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent)
• Prior experience working for a cell or gene therapy company

Responsibilities

• Ensure that Individual Case Safety Reports (ICSR) for assigned products are triaged, processed and submitted/distributed per global requirements and applicable SOPs
• Perform ICSR assessments (seriousness, expectedness, causality) for clinical trial safety reports, including review of Analysis of Similar Events, where applicable
• Manage key Pharmacovigilance governance meetings such as Safety Governance Board
• Review ICSRs for completeness and accuracy; draft queries and ensure appropriate follow-up
• Ensure the continuous oversight of the global safety database activities and any PV vendor with appropriate governance implementation
• Review key performance indicators in support of pharmacovigilance quality and vendor oversight
• Represent PV/Safety on clinical study teams. collaborate cross-functionally to deliver on PV and study objectives
• Lead or contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials
• Lead, manage and contribute to preparation and review of periodic reports (e.g. DSUR)
• Participate in SAE reconciliation, coding reviews and other study team activities
• Participate in protocol development to ensure effective collection of safety data. Review and provide medical content and analysis, as needed, for regulatory documents and key study-related documents (e.g. ICF, SMC/IDMC Charters, clinical study reports)
• Develop and deliver PV training materials including for Investigator Meetings or Site Initiation Visits
• Support PV-related inspection and audit activities
• Lead or contribute to the development of PV processes and procedures to assure completeness and accuracy of safety data collection and ensure compliance with all relevant regulations.
• Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed.

Benefits

• Dynamic workplace that balances remote work flexibility with the benefits of in-person interactions
• Collaborative work environment
• Mentorship opportunities
• Increased cross-functional communication
• Opportunities for employees to connect

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees