Associate Director, Global Patient Safety

The Associate Director, Global Patient Safety, is responsible for leading operational pharmacovigilance (PV) activities across global clinical development programs.

This individual serves as a senior safety operations lead, overseeing end-to-end PV processes including case management, vendor oversight, global regulatory compliance, audit readiness, and strategic input into safety systems and processes.

This role ensures operational excellence, inspection readiness, and contributes to the strategic evolution of the PV function.

Tasks & Responsibilities:

• Serve as Global Patient Safety Operations Lead across multiple clinical programs, ensuring operational excellence in PV activities from study start-up through closeout.
• Lead and oversee all case processing and safety reporting activities, ensuring compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA, EudraVigilance) and internal SOPs.
• Provide strategic oversight and management of CROs/vendors, including budget ownership, KPI development and monitoring, and performance reviews.
• Develop and maintain study-specific Safety Management Plans (SMPs), ensuring alignment with protocols, data collection tools (eCRFs), and reconciliation procedures (SAE, AESI, pregnancies).
• Ensure timely and accurate ICSR submission, case reconciliation, and global safety exchange with partners and regulatory agencies.
• Collaborate with partners on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements.
• Lead day-to-day operations of the PV Vendor through performance of Quality Check (QC) activities related to ICSR processing, regulatory reporting, and follow-up.
• Oversee PV contributions to clinical and regulatory documents, including protocols, investigator brochures, informed consent forms, DSURs, and CSRs.
• Support aggregate safety data reviews, signal detection activities, and cross-functional safety meetings.
• Drive development, review, and implementation of PV Standard Operating Procedures (SOPs), Work Instructions (WIs), and process improvement initiatives.
• Support PV readiness for health authority inspections and internal/external audits; act as subject matter expert during inspection-related activities.
• Provide PV training to internal and external stakeholders, including clinical teams, CROs, and investigators.
• Represent the PV function in cross-functional projects and contribute strategic safety input into corporate initiatives.
• Support safety database configuration and oversight, MedDRA/WHODrug updates, and system transitions as applicable.
• Mentor and support junior staff and lead PV operational sub-teams as required.

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Qualifications:

• Bachelor's degree in a life sciences discipline required; PharmD, MD, PhD, RN, or MSc preferred.
• Minimum of 10 years of biopharmaceutical industry experience, including at least 7 years in pharmacovigilance with increasing levels of responsibility.
• Strong knowledge of global PV regulations, ICH GCP, ICH and GVP Modules.
• Demonstrated experience leading pharmacovigilance operations and vendors, including case processing oversight and global safety reporting.
• Proficiency with safety databases (e.g., Argus), MedDRA/WHODrug coding, and electronic safety submissions.
• Experience contributing to or leading safety activities across multiple phases of clinical development.
• Strong communication and leadership skills, with proven ability to influence and manage in a matrix environment.
• Track record of audit and inspection readiness, including SME participation.
• Strategic thinker with attention to detail, accountability, and a drive for operational excellence.
• Ability to thrive in a fast-paced, evolving biotech environment, adapting quickly to shifting priorities.

WHAT WE OFFER

An exciting opportunity to join a company that offers a competitive total rewards package that includes:

• Full range of health benefits, including Medical, Dental & Vision, with options for 100% EMPLOYER PAID premiums for employee and family!
• Employee Stock Purchase Program (ESPP)
• Competitive salaries and bonus plans plus equity via Stock Options
• Free variety of snacks and beverages
• Health and Wellness programs
• $100 Anniversary cash awards with opportunity to increase to $2000!
• Referral Bonuses
• Company sponsored FUN events

Arcturus is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

For a deeper dive into our company and corporate culture visit www.ArcturusRx.com