Position: Pharmacovigilance Specialist
Location: Lawrenceville, NJ
Duration: 06 months+ Months (Extendable) Projected for 12 months and beyond depending on the business need.
This Position is Onsite
Pay Rate: $50-55.00/hr on W2 Paid weekly
Position Responsibilities
• Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting key MST activities, milestones, and documents to the MST Chair. Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.
• Author and contribute to specified PV sections of the PBRERs and DSURs with oversight, as needed
• Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to safety data/ad hoc queries and HA requests.
• Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
• Collaborate within and across BMS functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
• Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.
Key Competency Requirements
• Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
• 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.
• Ability to work well in cross-functional teams.
• Good collaborative and communication skills with scientific subject matter.
• 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).
• Understand aspects and methods for data analysis, interpretation and presentation.
• Possess good working skills in MS Word, Excel and PowerPoint, including statistics
