Susan Darrah-Reilly

About Susan Darrah-Reilly

Pharmaceutical:Responsible for safety and pharmacovigilance operational activities for all Acadia products. Oversee and manage PV vendors to ensure state of compliance. Collaborate with the Safety Physicians to provide necessary information for the identification and investigation of potential safety signals and contribute with the development of risk management and pharmacovigilance plans. Ensures compliance with timely reporting of the adverse events that meet regulatory requirements for submissions to the applicable Regulatory Agencies. Oversight, training and management of internal and CRO pharmacovigilance activities for global oncology trials, EAP programs, IITs, and the post-marketing space. Staff recruitment, performance review, and team mentoring and development.NDA/MAA submission document review including EU PSMF, SCS, ISS, CSR and RMP. Development and revision: RMP, IB, ICF, Protocols, Narrative, CSR, AERP, eCRF/SAE Completion Guidelines, Query tracking, Metrics, SAE forms, SOPs, submission documents, work instructions and processes.Individual case review, approval and submission, oversee/coordinate completion of aggregate reports, signal detection, labeling updates, risk assessment, literature review, and SAE reconciliation.Triage team leader Comprehensive adverse event processingExtensive legal and medical record reviewPrincipal author of global aggregate reports (DSUR, PBRER; and PV plans, Expert Report; Benefit/Risk Analysis; Addendum, Bridging, Expedited, and Annual Safety Reports)Coordinated and initiated Team Building ExercisesDevelopment and implementation of Team Integration PlanCreated PSUR Style Guide & Expert Statement TemplatesNursing:Director of 60-bed unitMedicare Case ManagerRN Assessment CoordinatorCoordinate and lead patient Care ConferencesEmployee performance reviewsStaff recruitment and schedulingSpecialties: Professional Nurse-RN,BSNPharmaceutical professional-MS in Quality Assurance and Regulatory Affairs

Experience

1. Senior Director

   Acadia Pharmaceuticals

   Mar 2023 — Present · Princeton, NJ, US

Education

• Temple University

  MS, Pharmaceutical Quality Assurance & Regulatory Affairs

• Gwynedd Mercy University

  ASN/BSN, Nursing

  1993 — 1997

Skills

• Clinical Study Design
• Pharmaceutics
• Clinical Trials
• Edc
• Ctms
• Clinical Research
• Ich-Gcp
• Drug Development
• Cancer
• Gcp
• Biotechnology
• Intercultural Communication
• Clinical Development
• CRO Management
• Oncology
• Protocol
• Pharmacovigilance
• Regulatory Submissions
• CRO
• Ind
• Life Sciences
• Clinical Trial Management System (Ctms)
• Regulatory Affairs
• Medical Writing
• Standard Operating Procedure (Sop)
• Pharmaceutical Industry
• Sop
• Fda
• Drug Safety
• Operations Management
• Vaccines
• Quality Assurance
• Gastroenterology