Remote Senior Director, Global Drug Safety Operations

BioSpace; Indianapolis (IN); Remote; USD 161.000 - 260.000; Vollzeit

Benefits dieser Stelle

Company bonus

Comprehensive benefits

Zusammenfassung

Centessa Pharmaceuticals is seeking a Senior Director of Drug Safety Operations to lead global pharmacovigilance, align safety activities with program goals, and develop a high-performing team. You will collaborate with Clinical Development, Regulatory Affairs, Quality, and external partners to ensure compliant, timely safety deliverables.

The role is remote in the US with potential travel; requires 10+ years in PV, strong leadership, and expertise in FDA/EMA guidelines, ICH GVP, and

Qualifikationen

• 10+ years of pharmacovigilance and drug safety operations experience.
• Experience supporting small molecule development and neuroscience/CNS products.
• Experience managing global safety operations including ICSR and regulatory submissions.
• Strong knowledge of FDA, EMA, MHRA, ICH, GVP and international reporting.
• Experience overseeing pharmacovigilance vendors and external service providers.
• Hands-on with safety databases like Argus or ArisG.

Aufgaben

• Lead Drug Safety Operations activities and manage team members.
• Implement and enhance operational processes, governance, and resourcing.
• Execute global Drug Safety Operations strategy and governance.
• Oversee pharmacovigilance operations including ICSR processing and SUSAR reporting.
• Govern pharmacovigilance vendors, CROs, and safety database providers.
• Maintain and improve SOPs, quality systems, and CAPA programs.
• Support aggregate safety reporting activities (DSURs, PBRERs, RMPs).
• Drive KPIs, dashboards, and data-informed decision making.
• Mentor and develop staff; foster accountability and collaboration.

Kenntnisse

Drug Safety Ops

Team Leadership

Regulatory Submissions

Cross-functional Collaboration

Safety Databases (Argus/ArisG)

GxP Compliance

Ausbildung

Advanced degree in science

Tools

Argus

ArisG

Jobbeschreibung

Centessa Pharmaceuticals is seeking a Senior Director of Drug Safety Operations to lead global pharmacovigilance, align safety activities with program goals, and develop a high-performing team. You will collaborate with Clinical Development, Regulatory Affairs, Quality, and external partners to ensure compliant, timely safety deliverables.

The role is remote in the US with potential travel; requires 10+ years in PV, strong leadership, and expertise in FDA/EMA guidelines, ICH GVP, and