The Associate Director/Director of Global Safety Compliance is accountable for the oversight of Global Safety Risk Management processes and procedures to ensure compliance with global regulatory requirements. This includes accountability for the Pharmacovigilance Quality System and oversight of the adherence to Global Safety Risk Management processes and procedures, Pharmacovigilance agreements, and Safety Management Plans. This position is accountable for strategic planning for Global Safety Compliance and serves as the representative for cross-functional project teams. This role is accountable for management, mentorship and guidance of the staff responsible for performing quality monitoring and documentation management, Global Safety Alliance Management and Aggregate Reporting activities. In addition, the Associate Director/Director of Global Safety Compliance serves as the department point of contact and provides strategic guidance and operational oversight for audits and inspections of Global Safety Risk Management.
* Accountable for the development and maintenance of the Pharmacovigilance (PV) Quality System with direct oversight of the management of the Pharmacovigilance System Master File (PSMF)
* Accountable for Global Safety Compliance processes in conjunction with the EU QPPV and Research and Development Quality Assurance.
* Provide oversight and strategic planning for the authoring, delivery, and change management of all training on Global Safety Risk Management processes and procedures in partnership with cross-functional stakeholders
* Serve as department liaison for audit/inspection activities in close partnership with Global Safety Compliance staff and Research and Development Quality Assurance
* Accountable for the authoring and approval of audit/inspection responses in close partnership with Research and Development Quality Assurance and other Global Safety Risk Management leadership; ensures compliance with audit/inspection response commitments
* Oversee Global Safety Alliance Management to ensure strategic alignment with existing and future partnerships and compliance of PVAs and SMPs with Global Safety Risk Management processes
* Oversee Global Safety Aggregate Reporting to ensure delivery of high quality reports that are compliant with global regulatory requirements
* Ensure continuous improvement with Individual Case Safety Report (ICSR) quality review processes and lead collaboration with other Global Safety Risk Management functions to drive quality issues to resolution
* Accountable for compliance with standard Key Performance Indicators (KPI), including vendor oversight, by monitoring compliance metrics and quality/ timeliness of Global Safety Risk Management deliverables
* Identify and champion process improvements, and oversee development, tracking and completion of action plans in partnership with Global Safety Risk Management staff and external stakeholders and ensure updates to documentation and training as required
* Provide oversight and approval of Global Safety Risk Management process deviations and CAPAs in alignment with corporate processes
* Provide leadership, management and mentoring of Global Safety Compliance staff including resource and career planning, goal setting and providing Performance Evaluation Assessments
* Perform other duties related to the position as required
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.