Manager, Case Management / 08-5147

Sanofi Pasteur in the USA is a leader in the research, development, manufacture, marketing and sales of vaccines and immunological products because here we clearly see a better tomorrow for all mankind.We have a wide range of vaccines that protect against 20 diseases, but we believe there is still much work to be done. On every continent there exists viruses and bacteria, and we won’t rest until they are eradicated and all people can live healthy, full lives. We’re confident we can achieve our goals. As a subsidiary of Sanofi Aventis, the global pharmaceutical corporation, we have access to the resources needed to continue our boundary-breaking innovations far into the future.Our US site is located in Swiftwater, Pennsylvania, among the scenic Pocono Mountains, sanofi pasteur is housed in state-of-the-art facilities on a 269-acre campus. It is here that our multidisciplinary teams of 1900+ professionals work together to develop and provide new and improved immunological products. Our company is comprised of three global functions: Research & Development, Industrial Operations, and Commercial Operations, as well as seven support functions: Communications, Corporate Development, Finance and Purchasing, Human Resources, Information Solutions, Legal and Corporate Affairs, and Public Policy.For those who wish to make a difference in the world by aiding in the development, production or marketing of vaccines that are critically important to public health, sanofi pasteur offers superb opportunities. Our modern research, production and administrative facility attracts exceptional talent from businesses and universities around the world. Our location offers our people the best of outdoor living close to the cultural, culinary and recreational attractions of Philadelphia and New York City.sanofi pasteur US is a place for those who desire a challenging and rewarding career without compromising their quality of life. If you have the passion, desire, ambition, vision and talent we’re looking for, we invite you to explore our opportunities and to apply online at: www.sanofipasteur.us

Position Description:

The Case Analyst processes individual adverse event cases related to licensed and investigational products through a triage step, performs full record completion and assessment of the case within regulatory timelines and ensures follow-up of the case for missing information; works cooperatively with safety officers across product franchise groups to ensure case quality.* Triage individual adverse event cases according to criteria identified for category 1, category 2 case. * Complete data entry of case into ARISg database including single case narrative, laboratory data fields, past medical history, coding, ranking and assessment of listed ness of adverse events and products with individual accountability on quality of own work and specified other fields entered into ARISg by Reception/DE personnel. Ensure timely completion and assessment of all cases in order to lock and approve all non-serious cases (category 1 cases) and to forward serious cases (category 2 cases) to safety officer for medical assessment and lock and approve activity. * Manage the follow-up for missing data on adverse event reports using the communication screen and BO queries. Provide guidance to assistant assigned to prepare letters and CIFs (follow up request to investigators for investigational products). Contact reporter directly by telephone or e-mail as necessary. * Maintain continuous and open communication with safety officers, reception /DE personnel, quality /compliance officers and PSUR support group. Participate in regular Franchise team meetings and share information within the Case Management platform to promote consistency and improve case quality. * Assist the study teams with the reconciliation of safety information including demographic data for clinical studies.* Query on ARISg with Business Object, to retrieve cases in the management of Case Management platform activities.* Organizing, prioritizing and completing quality adverse event processing within regulatory time frames as unexpected demands and deadlines fluctuate with the volume of incoming adverse event reports at the local sites. * New role and responsibilities require development of new assessment skills to achieve and maintain excellence in the quality of adverse event processing.* Planning and interfacing effectively with Study teams to receive follow-up information necessary in a well documented report and expedite PV and clinical database reconciliations to avoid scheduling last minute re-work of cases and heavy workloads.We are an equal opportunity employer M/F/D/V

Qualifications:

• Preferred: pharmacist, or degree in nursing (BSN, BScN) or biological science degree. Bachelor's degree required• 3 years experience in pharmaceutical industry• Training on computer/software