Submissions to Investigators, Regulatory Agencies and Ethics Committee

Submissions to Investigators, Regulatory Agencies and Ethics Committee

Submissions to Investigators, Regulatory Agencies and Ethics Committee

Responsible for the overall management and guidance to the Safety Administrative Manager group for the coordination of multiple Pharmacovigilance (PVG) administration teams across North America and Latin America PVG locations.

Responsible for the coordination, management and operation of the safety support staff to support the Pharmacovigilance (PVG) Director, Medical Monitors, Associate Directors, Team Managers, and Safety Specialists. Coordinated the non-safety/safety aspects of PVG projects and provides technical expertise, coaching/training and guidance to the safety support staff. Other responsibilities include supervising safety support personnel, allocating support resources, and the coordination of safety management responsibilities in accordance with organization goals and objectives for multiple simple/complex, domestic/international studies.

Provides lead coordination for project support and provide the safety support team with work direction for complex and non-complex global and domestic studies. Responsible for resolving complex project support problems through in-depth evaluation of various factors. Serves as mentor for junior safety support staff for SAE tracking and safety database activities, narrative generation, QC activities, reconciliation, SMMP/process flow preparation, proposal/contract mod preparation and budget maintenance. This position will provide assistance to Safety management in the supervision of the safety support staff and their assigned SAE processing, medical management as well as administrative responsibilities for the Pharmacovigilance Department.

Provides primary Records Management and file room support for multiple studies at any given time• Responsible for training and mentoring new Records Management staff• Works on special projects as assigned by Records Coordinator.• Responsible for ensuring file room security and that all Records Management tasks are completed according to PPD/and or Client SOPs/WPDs• Works closely with clinical administration and clinical project team members

􀂃 Provides primary Records Management and file room support for multiple studies at any given time􀂃 Works on special projects as assigned by Records Coordinator􀂃 Responsible for ensuring file room security, cleanliness and that all Records Management tasks are completed according to PPD/and or Client SOPs/WPDsWorks closely with clinical administration and clinical project team members