Associate Director, Pharmacovigilance Operations

Job Description:

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

Position Summary

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.

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.

Minimum Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related life science.
• Prior pharmacovigilance experience with a demonstrated track record of significant accomplishments:
  • 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

Preferred Qualifications

• 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

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy