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Senior Pharmacovigilance Scientist - United States  

Company managed [?] Still accepting applications

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.