Signal Detection/Drug Safety Associate II Job at Integrated Resources, Bridgewater, MA

V1IreDhwdXB0T1IyOGd4Yi9mVTBtb1kzdnc9PQ==
  • Integrated Resources
  • Bridgewater, MA

Job Description

Signal Detection/Drug Safety Associate II

Contract

Job Title: Signal Detection/Drug Safety Associate II

Responsibilities


  • The contractor resource will be the key contact on the SM Simplification Project work streams.
  • Bring industry expertise to support the Simplification Project and will provide strategic feedback to GSS and project team.
  • Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool.
  • Assess currently utilized quality documents and develop/modify business processes as needed.
  • Develop training materials and provide training.
  • Develop and implement a consistent process to produce KPIs.
  • Work closely with PM to ensure that timelines are met.
  • Coordinate and lead SMC meetings.


Qualifications
  • Experienced in signal detection tools and processes
  • Skilled in implementing new business processes and technology solutions for signal detection in clinical development
  • Experienced in LEAN methodology
  • Working knowledge of regulations related to signal detection (GVP Module IX)
  • Proven expertise working with FAERS and WHO-Vigibase data
  • Ability to review complex information to develop business related strategies for integration of clinical development data and real-world data in the signaling process
  • At least 5+ years of pharmacovigilance experience, especially in signal detection and management
  • Strong consulting experience
  • Excellent Excel/WP/PowerPoint and technical writing skills
  • Clinical experience a plus



Education

Education:

#J-18808-Ljbffr

Job Tags

Contract work, For contractors,

Similar Jobs

Hayman Daugherty Associates

Physician / Surgery - Orthopedics / Georgia / Permanent / Orthopaedic Trauma Surgeon Opportunity in Job at Hayman Daugherty Associates

 ...Seeking an Orthopaedic Trauma Surgeon to join a permanent practice in Georgia Primary Specialty: Orthopaedic Trauma Surgeon Candidate must be Fellowship trained in Ortho Trauma Surgery Provider must be BC/BE in Ortho Surgery Located near Tignall, GA If you are interested... 

University of Miami

Research Laboratory Technician Proteomics Job at University of Miami

 ...Research Laboratory Technician The University of Miami/UHealth Department of Sylvester Comprehensive Cancer Center is seeking a motivated...  ...laboratory on a full-time basis at the University of Miami medical campus in Miami, Florida. This is an exciting opportunity to... 

CONAGRA

Production Specialist Job at CONAGRA

 ...Conagra Brands is an equal opportunity employer and considers qualified applicants for employment without regard to sex, race, color, religion, ethnic or national origin, gender, sexual orientation, gender identity or expression, age, pregnancy, leave status, disability... 

Parsons Company

Research Scientist I Job at Parsons Company

 ...Research Scientist I In a world of possibilities, pursue one with endless opportunities. Imagine Next! When it comes to what you want...  ...Parsons is seeking a Research Scientist I to support Naval Medical Research Unit San Antonio (NAMRU-SA) and its collaborating institutions... 

General Dynamics Electric Boat

Test Engineer Job at General Dynamics Electric Boat

Job Description Overview This position in a growing, high profile department is looking for enthusiastic individuals to guide project teams to identify, assess, and mitigate inordinate risks to ensure successful execution of complex tasks. To achieve these goals,...