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Senior Manager, Clinical Safety Scientist

Basking Ridge, NJ 07920

Posted: 08/09/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 569966 Is job remote?: Yes Country: United States

Job Description

Target Pay Rate: 60-80/hr **salary will be commensurate with experience 

Job Summary:

  • Position independently handles aspects of signal identification, evaluation, and risk mitigation across therapeutic areas.
  • This position proactively creates communication plans for important safety topics and identified risks.
  • Additionally, this position may serve as primary author for certain safety documents and regulatory submissions and reviews protocols and ICFs.
  • Additionally, this position project manages larger Phase 3 or 4 SMTs and supervises junior scientist project managing smaller SMTs.
  • This position works closely with CSPV staff, SMT members, and occasionally IPT members and other functions.
  • Finally, this position works on the most complex problems and makes decisions regarding project management work within CSPV.


Risk Management (Signal identification, evaluation, mitigation):
  • Is a key participant in developing, and possibly implementing, the risk management strategy for assigned products/ TAs.
  • Demonstrates familiarity with PV/Epi related literature.
  • Assists CS physician in assessing new signals.
  • May independently integrate and analyze safety data from multiple sources to deliver comprehensive conclusions.

Safety Communication:
  • Develops strategy for communicating safety information internally and externally with CS physician.
  • May first author safety communications.

  • Documents meeting discussions, decisions, action items, and SMT activities independently.
  • Ensures the appropriate archiving of the team meeting documentation and SMT activities independently.
  • Maintains a current signal tracking log independently.

Project Management:
  • Serves as PM for SMTs devoted to larger Phase 3/4 products and ensures adherence to project timeline.
  • Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately.
  • Coaches, mentors, and influences junior scientists and team members.
  • Possesses strong medical or TA and drug development knowledge
  • 6 or more years pharma-related experience with an advanced degree
  • Bachelor's Degree required
  • PharmD/PhD preferred

**CO/NY candidates may not be considered 
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