BrightOwl Loader Loading

Senior Pharmacovigilance Scientist Santa Monica United States,  

Job Score (company)


Posted on : 06 June 2017

Project Description

Description:
  • Our company  is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. 
  • The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. 
  • The Safety Scientist is responsible for or supports various pharmacovigilance and risk management/minimization activities for company s investigational and marketed products



Roles and Responsibilities include (but are not limited to): 
  • Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) in accordance with company  SOPs and regulatory requirements 
  • Support preparation and maintenance of Risk Management plans 
  • Contribute to development of signal detection strategy for post marketed products 
  • Support signal detection, evaluation and management according to company SOPs and guidelines 
  • Support development and/or maintenance of core and local label for products (e.g., CDS, USPI, SmPC, IB, etc) 
  • Serve as the Safety Lead for one more company clinical programs 
  • Assist in oversight of Pv vendors/CROs as applicable 
  • Contribute to preparing safety assessments reports 
  • Participate in preparing responses to safety related requests from health authorities 
  • Provide safety content review of clinical protocols, CSRs, and ICFs 



Experience, Skills, Knowledge: 
  • Ability to critically analyze individual and aggregate safety data with scientific rigor 
  • Previous experience in preparing periodic safety reports and risk management plans 
  • Strong relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting 
  • Excellent written and verbal communication skills to a variety of levels and teams, internally and externally. 
  • Demonstrated persuasion, influencing and negotiation skills 
  • Ability to operate objectively and independently as a leader and as a member of a team, as required 
  • Effective team player, with proven ability to effectively lead projects and teams to successful conclusion. 



Requirements: 
  • Bachelor's level degree in life sciences required; MD, PharmD or PhD highly preferred. 
  • At least 5 years of direct Pharmacovigilance Safety Science is required. 
  • Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines. 
  • Strong knowledge of safety database (preferably ARGUS), MedDRA, and WHO Drug 
  • Strong quality focus, with a good understanding of quality systems. 
  • Excellent communicator, both oral and written, specifically medical writing skills 



About Us:
  • Our company is  an equal opportunity employer.
  • We are able to offer the opportunity to be part of this successful, fast growing company.  A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.  

Locations

Santa Monica CA

Find a Job Find Candidates

Similar Jobs

More jobs from Kite Pharma

Other jobs in United States

Other jobs in Santa Monica

Other similar job in Santa Monica

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like