Pharmacovigilance/Global Regulatory Affairs Manager

Pharmacovigilance/Global Regulatory Affairs Manager. IQVIA RDS Inc. Durham, NC. 4 OPENINGS. May telecommute from anywhere in the U.S. and report electronically to the Durham, NC headquarters. Accurately collect, document and report adverse events occurring in clinical trials and in the post-marketing environment according to current global regulations, implementing specialized safety databases, including Oracle Argus and ARISg, and electronic data capture systems, such as, Medidata RAVE, Oracle InForm, and IBM Clinical. Process clinical data, including receipt, entry, verification, or filing of information. Design and validate clinical databases, including the design and test of logic checks. Code medical terminology using the Medical Dictionary for Regulatory Activities and medications using the World Health Organization Drug Dictionary. Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems. Utilize Oracle Application Express databases, Infosario Analytics reports and Oracle Business Intelligence Enterprise Edition reports to oversee project deliverables and team performance. Develop project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, and workflow processes. Receive and transmit Individual Case Safety Reports via electronic data interchange. Stay up to date on knowledge of applicable global, regional and local drug development and marketed product safety regulations and requirements. Project management; including planning, organization, and conflict resolution among team. Collaborate with internal functional teams, as well as client teams. Maintain effective working relationships with co-workers, managers and customers. Deliver on multiple projects and manage competing priorities. Responsible for tactical planning and budgeting of projects.

Requires at least a Bachelor's degree in Pharmacy Administration, Pharmaceutical Marketing and Management, Clinical and Industrial Drug Development or related field or foreign equivalent and four (4) years of Pharmacovigilance, Clinical Event Validation and Adjudication, Medical Information, Safety Report Publishing, or Risk Management experience to include three (3) years: project management including project oversight for case processing activities and timelines; communication with clients and project managers; providing leadership to teams and coaching junior staff; ensuring financial project performance through oversight of key performance metrics; and successfully implementing and driving process initiatives. Apply: Send resume to emily.kuykendall@iqvia.com and reference job id#106922.