Assists the director in ensuring the delivery of safety management services consistent with company SOPs/WPDs, ICH guidelines and regulatory requirements. Works with managers and liaises with other departmental personnel as required. Responsibilities include the general oversight of PVG operations and management of activities of managers, Safety Specialists, and other staff including, the development and maintenance of departmental SOPs/WPDs and long-range planning for new processes and staffing needs. Additional responsibilities include participation in the development of business proposals and client presentations, and interacting on a daily basis with members of the Business Development in Bids and Contracts groups.

Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management, and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team.

Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management, and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team.

Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management, and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team.

- Manages Safety team members responsible for all Safety services while adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, Good Pharmacovigilance Practices (GVP) and study procedures.- Participates in process development, budget reviews, and project management. Ensures consistency and communication between the Safety team members and management.- Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling.- Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives.- Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan.- Manages projects where Safety and Pharmacovigilance are the primary services.- Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed.- Provides sponsors with scheduled project updates and reports.- Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan.- Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings.- Participates in bid defense meetings.- Responsible for the identification, preparation, and delivery of any necessary training to Safety team members.- Managing resourcing's needs/issues and escalating to senior management as necessary.- Participates in audits/inspections and ensures inspection readiness.- Participates in quality investigations and implementation of corrective and preventive actions.

- Performed all aspects of the collection, processing, and reporting of adverse events/endpoints adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, and study procedures.- Served as Team Lead for several projects.- Managed daily workload of Safety Specialists within the department with limited line management responsibilities.- Mentored and trained junior Safety Specialists.- Ensured that the project activities were completed in a timely manner with acceptable quality and acted as a decision maker.- Supported business development activities and delivered presentations including participation in request for proposals (RFP) and Bid Defenses.- QC of team cases.

- Performed day-to-day processing of adverse events for assigned projects under the direction of more senior safety personnel; provides oversight and project guidance to junior safety personnel; oversees all aspects of safety reporting for assigned projects.- Served as Team Lead- Performed and coordinated case report reconciliation, both with source documents and between the clinical and safety databases.- QC work of safety data coordinators and more junior safety specialists.- Mentors existing and new staff within the department with regard to AE/SAE reporting process and regulatory reporting requirements.- Actively involved in discussions and study training meetings- Gave presentations as requested to internal associates, clients, or others.- Liaised with other departments on shared responsibilities such as CDM for reconciliation for safety issues.- Single point of contact for information regarding the project.- Primary safety contact with the sponsor.- Prepare/approve project safety plan.- Trained personnel on the team.- Reviews financial measures.- Coordinated workload and work flow for assigned studies.- Leader of group meetings.- Served as technical resource.

Assisted in the day-to-day processing of adverse events for assigned projects under the direction of more senior safety personnel.- Entered and verified each and every data field in safety database, or sponsor database as appropriate.- Coded all adverse events, indications, medical history, and medications.- Prepared narratives.- Forwarded reports in a timely fashion to safety medical officers.- Participated in case quality assurance checks from above (medical officer or more senior safety specialist) and below (data entry staff).

- Reviewed and processed clinical trial data to ensure accuracy and consistency of clinical databases. CRF tracking, reviewing, validation, updating, and safety coding.- Provided accurate, timely, and consistent clinical data to both sponsors and other internal SBUs to support the business needs.