The Associate Director, Drug Safety Operations is responsible for operational management and leadership of case processing activities. The role is responsible for managing Case Coordination, Management, and Submission activities within Drug Safety Operations to ensure all ICSR processing comply with regulatory requirements and corporate and departmental procedures. This position requires the ability to influence and lead a diverse team, ensure strong partnership with internal and external partners and with senior management. The incumbent is accountable to compliance with all applicable local and international regulations and company Standard Operating Procedures.
* Provides subject matter expertise to Global Safety Operations (GSO) regarding ICSR processing and related regulations, systems, procedures and deliverables
* Oversight and personnel management across GSO Case Management, including goal setting, Manager performance evaluation assessments, and mentoring/career development
* Provide subject matter expertise on safety operations and overall data quality during audits/inspections as required
* Ensure timely submission of expedited safety reports and other external submissions through effective vendor (SMP) management and performance metrics review
* Lead and/or provide functional support for the maintenance and continuous improvement of internal and external case processing (e.g., quality evaluations and metrics)
* Effectively manages interactions with CROs and ensure highest quality of deliverables
* Provide functional support to other GSRM and GSO functions to ensure robust processes conducive to seamless case management activities and deliverables. Provide input as required to business requirements, vendor selection, contract details, vendor oversight /safety management plans (SMP), Pharmacovigilance Agreements (PVAs); review and approve governing documents, such as SOPs, Work Instructions / Training Guides and ensure seamless operational implementation
* Foster strong professional relations with other internal functions, e.g. Data Management, Biometrics, Quality Assurance, Regulatory, and others to optimally collaborate as a team
* Provide oversight and/or functional support for the Drug Safety Database System Owner.
* Other responsibilities 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.