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Associate Director Global Patient Safety
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Associate Director Global Patient Safety
Associate Director, PV Case Operations – Global Patient Safety
About Regeneron and the Role
At Regeneron, we leverage science and innovation to develop life-changing medicines for people with serious diseases. We’re seeking an Associate Director of PV Case Operations to join our Global Patient Safety team, responsible for supporting case processing across global development and commercial programmes. The role operates in a hybrid work mode, enabling flexibility while ensuring impactful contributions to patients worldwide.
Key Responsibilities
- Own and oversee accurate, timely case processing for both clinical trial and post-marketing environments, adhering to regulatory requirements and Regeneron’s standard operating procedures.
- Lead vendor oversight for end-to-end Individual Case Safety Report (ICSR) receipt, processing, distribution, and submissions.
- Ensure ICSR quality governance, including narrative validity, risk apportionment, and source document reconciliation.
- Establish tiered quality review frameworks based on case complexity, risk, and product lifecycle stage.
- Monitor submission timelines, vendor service-level agreements (SLAs), and inspection readiness, while addressing audit findings and regulatory requests.
- Lead and drive root cause analyses (RCAs) and oversee corrective and preventive action (CAPA) workflows, ensuring effective closure and follow-up.
- Evaluate AI-enabled tools for process optimisation, including data ingestion, workflow automation, and metrics-driven improvement.
- Mentor staff, collaborate with senior management, and act as a critical partner with vendors, cross-functional teams, and Health Authority (HA) inspectors.
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Requirements
Education & Experience
- Pharmacy, nursing, or equivalent qualification is required; an advanced degree is a strong advantage.
- Typically 10+ years of experience in one of the following fields: Pharmacovigilance (PV), Drug Safety, PV Quality, Medical Affairs, or equivalent in pharma or biotech.
- Comprehensive knowledge of FDA, EU, and ICH guidelines for clinical trial and post-marketing pharmacovigigilance.
- Experience managing cross-functional teams involved in complex, global projects.
Skills & Competencies
- Proven ability to deliver project outcomes through clear leadership, direction-setting, or oversight of individual contributors.
- Strong communication, negotiation, and conflict resolution skills; capable of escalating complex issues effectively.
- Prior experience navigating regulatory submissions, compliance audits, and determining case validity in high-stakes environments.
Location & Employment Terms
- RemoteHybrid (Uxbridge, UK)
- Engagement will likely involve onsite workforce requirements—please consult your recruiter for details.
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A Culture of Inclusion & Impact
Regeneron is committed to fostering an inclusive workplace where everyone’s contributions matter. As an equal opportunity employer, we ensure equitable consideration for all applicants without regard to race, religion, gender identity, disability status, or other protected characteristics.
Compensation & Benefits
Regeneron offers a competitive and comprehensive rewards package, which may include:
- Performance-based bonuses or incentive plans
- Equity awards
- Pension/retirement planning, 401(k) matching, health/wellness benefits
- Tuition assistance or continuing education programs
- Generous paid leave policies and family support benefits
For U.S.-based roles, full details can be found at Working at Regeneron. Global applicants will receive further information during the recruitment process.
Regulatory Expectations
Background checks will be performed in accordance with local laws to verify qualifications, identity, and work eligibility. Apportionment considerations extend to rare conditions that may arise during the course of employment.
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