Bsn Susan Darrah-Reilly Ms
Pharmaceutical: Responsible for safety and pharmacovigilance operational activities for all Acadia products. Oversee and manage PV vendors to ensure... | Princeton, New Jersey, United States
Bsn Susan Darrah-Reilly Ms's Emails sd****@ac****.com
No phone number available.
Bsn Susan Darrah-Reilly Ms's Location Princeton, New Jersey, United States
Bsn Susan Darrah-Reilly Ms's Expertise 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 processing Extensive legal and medical record review Principal 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 Exercises Development and implementation of Team Integration Plan Created PSUR Style Guide & Expert Statement Templates Nursing: Director of 60-bed unit Medicare Case Manager RN Assessment Coordinator Coordinate and lead patient Care Conferences Employee performance reviews Staff recruitment and scheduling Specialties: Professional Nurse-RN,BSN Pharmaceutical professional-MS in Quality Assurance and Regulatory Affairs
Bsn Susan Darrah-Reilly Ms's Current Industry Acadia Pharmaceuticals
Bsn Susan Darrah-Reilly Ms's Prior Industry Langhorne Gardens Nursing And Rehabilitation Center | Telerx | Wyeth | Bristol Myers Squibb | Taiho Oncology | Acadia Pharmaceuticals
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Bsn Susan Darrah-Reilly Ms is located at
Princeton, New Jersey, United States -
Bsn Susan Darrah-Reilly Ms is a
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 processing Extensive legal and medical record review Principal 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 Exercises Development and implementation of Team Integration Plan Created PSUR Style Guide & Expert Statement Templates Nursing: Director of 60-bed unit Medicare Case Manager RN Assessment Coordinator Coordinate and lead patient Care Conferences Employee performance reviews Staff recruitment and scheduling Specialties: Professional Nurse-RN,BSN Pharmaceutical professional-MS in Quality Assurance and Regulatory Affairs Acadia Pharmaceuticals -
Bsn Susan Darrah-Reilly Ms currently works in the
Acadia Pharmaceuticals -
Bsn Susan Darrah-Reilly Ms specializes in
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 processing Extensive legal and medical record review Principal 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 Exercises Development and implementation of Team Integration Plan Created PSUR Style Guide & Expert Statement Templates Nursing: Director of 60-bed unit Medicare Case Manager RN Assessment Coordinator Coordinate and lead patient Care Conferences Employee performance reviews Staff recruitment and scheduling Specialties: Professional Nurse-RN,BSN Pharmaceutical professional-MS in Quality Assurance and Regulatory Affairs -
Bsn Susan Darrah-Reilly Ms speaks the following languages:
No languages available. -
Bsn Susan Darrah-Reilly Ms has prior experience in the following industries:
Acadia Pharmaceuticals , Acadia Pharmaceuticals , Taiho Oncology , Bristol Myers Squibb , Wyeth , Telerx , Langhorne Gardens Nursing And Rehabilitation Center -
Bsn Susan Darrah-Reilly Ms has the following professional experience:
Acadia Pharmaceuticals , Acadia Pharmaceuticals , Acadia Pharmaceuticals , Taiho Oncology , Bristol Myers Squibb , Wyeth , Telerx , Langhorne Gardens Nursing And Rehabilitation Center . -
You can view Bsn Susan Darrah-Reilly Ms’s
LinkedIn profile at LinkedIn URL. -
Bsn Susan Darrah-Reilly Ms’s work email addresses are
[email protected] . -
Bsn Susan Darrah-Reilly Ms works at
Acadia Pharmaceuticals
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