Title: GPVE SAFETY SURVEILLANCE SCIENTIST
Location: NA-US-CT-Wallingford
Job Number:_1204069
RESPONSIBILITIES: 1. Lead cross-functional Medical Surveillance Teams (MSTs) and assigned subteams, such as Clinical Data Review (CDR) Teams, and participate in related PV and product-development subteam(s). Communicate issues impacting MST activities, milestones, documents to the MST Chair. 2. Manage resources and activities of MST/assigned subteams to maximize quality and efficiency in PV assessment on behalf of the assigned development/product team(s). 3. Provide periodic review and summary of pertinent safety-related literature and analyze pre-determined core signal data for MST Chair guidance. Appropriately elevate urgent issues identified to the MST Chair. 4. Work in collaboration and build strong relationships with appropriate disciplines, such as Medical Writers, to identify and ensure management of internal and external documentation support when required. Support Medical Writers in promoting team use of BMS standard document management and publishing processes for MST outputs. 5. Create MST/assigned subteam meeting agendas and accurately document decisions, conclusions, timelines, milestones and action items in team minutes. Verify completion of action items to ensure that appropriate data, strategy, project milestones and individual member responsibilities are addressed and fully communicated. 6. Work with team leads to ensure strategic aggregate report document plan, logic, and consistency. 7. Work with team lead to coordinate integration of the scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support scientific response to ad hoc queries and HA commitments. Review and contribute as author to ad hoc queries, and other strategic PV documents (eg, RMPs, INDs, NDA).
Qualifications:
REQUIREMENTS: 1. MS,RN/PharmD/PhD/MD or equivalent; with relevant scientific experience and/or training discipline. Minimum of 2 to 3 years in pharmaceutical field, or equivalent. 2. Good working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements. 3. Good working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality. 4. Ability to work well in cross-functional teams. 5. Strong collaborative and communication skills with scientific subject matter. 6. Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents). 7. Understand aspects and methods for data analysis, interpretation and presentation. Possess good working skills in MS Word, Excel and PowerPoint, including statistics
Job: Medical Affairs
