Drug Safety Alliance (DSA), located in Durham, N.C. is seeking a talented Project Manager.  DSA is a full-service outsourcing provider with an exclusive focus on drug safety. Our clients are large, midsize, and emerging pharmaceutical and biotechnology companies, both domestic and international. We support over 500 pharmaceutical and biological products internationally.   DSA effectively manages a suite of services including case management, regulatory consulting, quality management, and a secure, validated safety database.

SCOPE:

Provide Pharmacovigilance support and guidance to drug safety associates and clients in accordance with   DSA working practices and standard operating procedures to fulfill all strategic and tactical drug safety management.

RESPONSIBILITIES:

·         Directly supervises all assigned drug safety associates. 

·         Carries out supervisory responsibilities in accordance with DSA policies and applicable laws. 

·         Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and coaching employees; addressing complaints and resolving issues.

·         Develop and maintain strong, collaborative relationships with assigned clients.

·         Develop the team project leads to assume primary responsibility for day-to-day client management.

·         Work collaboratively with other Project Managers and Ops Management to strive to meet all Company goals and objectives.

·         Set, communicate and monitor performance expectations for staff; team productivity and quality standards will mirror or exceed DSA goals.

·         Develop, implement and maintain consistent working processes on behalf of DSA and all DSA clients to achieve operational efficiencies.

·         Chair and/or participate on Task Forces/Committees, as requested.

·         Ensure project team deliverables are completed in a timely manner. Utilize all available system(s) reporting capabilities to facilitate effective oversight.

·         Apply expertise in Chapter 21 Code of Federal Regulations specifically relating to drug safety post-marketing and clinical responsibilities.

·         Respond to inquiries from clients, healthcare professionals, consumers and company personnel regarding safety issues with marketed and/or investigational products.

·         Ensure timely submission of AE/SAE reports to domestic and worldwide regulatory agencies in accordance with applicable regulations.

·         Ensure timely submission of all client-requested reports.

·         Ensure that all inquiries from FDA for additional case information or clarification (telephone and written) are responded to in a timely and appropriate manner.

·         Analyze and document internal procedure deviations from DSA SOPs and WPs per client.

·         Evaluate and communicate procedural deviation impact on DSA personnel. 

·         Demonstrate a sound knowledge of the safety database including searching techniques, coding conventions and report generation.

·         Demonstrate a sound knowledge of all aspects of case processing.

·         Ensure DSA client projects maintain consistency with regulations, standard form usage, SOPs, WPs, and client-specific documentation.

·         Ensure all applicable client specific documentation is developed and updated in a timely manner.

·         Work collaboratively with appropriate DSA Staff to ensure all team members are appropriately trained on DSA SOPs/WPs and all client-specific documentation.

·         Work collaboratively with appropriate DSA Staff to ensure all team members obtain and maintain applicable case processing qualification status.

·         Provide DSA Management updates/status/metrics reports in a timely manner, as requested.

·         Respond to QRC for overall quality assurance issues identified during internal compliance audits.

·         Other duties as assigned.

QUALIFICATIONS:

·         BS in a science or healthcare related field (pharmacy or nursing strongly preferred) with a minimum of three years’ relevant industry experience.

·         Or Associate’s degree in nursing, RN and a minimum of five years’ relevant industry experience or a combination of relevant education plus a minimum of three years of applicable industry experience is required. 

·         Minimum of two years personnel management experience strongly preferred.

·         Complete understanding of all applicable 21 CFR Regulations surrounding the pre and post-approval data management activities with reporting of adverse event information is required.

·         Ability to work in an environment of rapidly changing priorities and client assignments.

·         Ability to assume leadership and management responsibilities for people and projects.

·         Ability to manage multiple activities and assignments.

·         Ability to work both as a member of a team and in an independent, self-directed manner.

·         Ability to manage and organize work to meet timelines and to meet the attention of detail required to successfully complete assignments.

·         Ability to communicate effectively in English, both orally and in writing.

·         Ability to maintain client and corporate confidentiality.

·         Ability to problem solve and trouble shoot in area of expertise.

·         Ability to interpret SOPs and WPs.

·         Proficiently utilize MS Office including, Excel, MS Word and any other required software.

Drug Safety Alliance offers competitive compensation, an attractive benefits package, the opportunity for professional advancement, and career growth.  If you meet the position requirements and are seeking an opportunity to contribute in a dynamic, small company environment, please submit a resume and salary history to email your resume to:   resumes@mindspring.com

Drug Safety Alliance is an Equal Opportunity Employer.