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Senior Manager
Pharmacovigilance Scientist
Posted on 8/29/2022
INACTIVE
Locations
Princeton, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Data Analysis
PowerPoint/Keynote/Slides
Word/Pages/Docs
Requirements
  • Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience
  • 3 - 5 years relevant Pharmacovigilance/Pharmaceutical Industry experience
  • 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
  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
  • 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
Responsibilities
  • Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile
  • Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health authorities, with oversight
  • Execute strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document signal by Safety Topic Review/ Signal Report
  • Analyze data and prepare documentation to support label updates for assigned products, with oversight
  • Support Safety input for regulatory product labeling
  • Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products
  • Working 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
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.