Purpose/Objective of the job
Support Medical Safety Assessment Physicians (MSAP with cross-functional Medical Surveillance Teams (MSTs) and assigned subteams, such as Safety Data Review (SDR) Teams. Appropriately elevate program or portfolio issues impacting key MST programs, priorities, resources, milestones. Contribute to regulatory documents and assist with projects.
Key Responsibilities and Major Duties
1. Participate in cross-functional Medical Surveillance Teams (MSTs) and assigned subteams, such as Safety Data Review (SDR) Teams, and participate in related PV and product-development subteam(s). Appropriately elevate issues impacting key MST activities, milestones, documents to the MST Chair.
2. Periodic review of pertinent safety-related literature, analysis of pre-determined core signal data. Provides advice and summaries, evaluations and conclusions of safety data reviewed.
3. Collaborate within and across BMS functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
4. Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Mentor individuals and teams on these applied learnings.
5. Coordinate and integrate scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to ad hoc queries and HA commitments. Contributing to and authoring regulatory documents.
Manager is looking for someone with data analysis, literature review, PBRER writing, aggregate report writing.
Interested candidates may contact at "Praveen.arora(@)artechinfo.com or 973-507-7593"