Associate Director, Pharmacovigilance Operations

Role Summary

Associate Director, Pharmacovigilance Operations to manage global case processing, safety reporting, and vendor oversight for our clinical programs. Will contribute to a full range of pharmacovigilance activities: overseeing the management of individual case safety reports (ICSRs), supporting PV vendors, and safety governance. Works 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.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related life science.
• 12+ Years of relevant experience with a bachelor's degree; 10+ Years 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

Skills

• 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.