at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
This Associate Director, Pharmacovigilance Operations will be responsible for managing global operational teams and overseeing processes and functions for handling of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials. The Associate Director will be responsible for ensuring compliance with operational procedures and regulations for all Pharmacovigilance functions (post-marketing and clinical trials). The position will also be responsible to provide management and guidance of activities including support of the QPPV, support of aggregate reporting/risk management team processes, and assistance with maintaining relationships with intradepartmental teams, external service providers/vendors and business partners.
Essential Functions of the Job (Key responsibilities)
Direct global DSA teams with processing of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials to ensure high quality case reports and submissions compliance.
Provide functional oversight over clinical trial and post-marketing pharmacovigilance processes and submission activities.
Direct literature review and associated processes.
Support the aggregate reporting and risk management.
Support the QPPV and Senior Management as required.
Manage quality and compliance metric oversight and trend analysis, and identification and correction of quality and compliance issues.
Assist to develop business partner agreements and lead teams working under business partner agreements.
Direct Pharmacovigilance representatives on intradepartmental, business partners, and vendor teams.
Provide in-depth technical expertise on Pharmacovigilance processes and systems.
Assist with directing CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
Assist to Direct audit and inspection processes as required, including serving as functional subject matter expert as required.
Ensure compliance with Pharmacovigilance data reconciliation processes, and work to resolve/escalate issues as appropriate.
Actively identify process improvement and efficiency needs and develop solutions as appropriate.
Develop procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes.
Direct resource management processes for assigned teams, including recruitment of staff, line management of assigned staff and succession planning.
Develop staff in assigned functional Pharmacovigilance processes, project and team management, and encourage growth by provision of regular mentoring and performance feedback.
Assist with vendor oversight, including identification of out of scope needs, quality and resourcing issues, and escalation of issues as appropriate.
Direct and ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
Ensure files and systems are maintained as appropriate.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree in a science or healthcare related discipline (nursing/pharmacy preferred), or equivalent.
Minimum of 8 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience, with an additional 5 years' management experience.
Safety database system expert (Argus required).
Expert knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
Demonstrates accountability and responsibility for both director role and assigned team.
Demonstrates leadership ability.
Advanced project and staff management skills.
Expert organizational, time management, and problem-solving skills.
Advanced proficiency with creating and delivering presentations.
Excellent verbal and... For full info follow application link.
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