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Sr. Drug Safety Associate
Ref No.: 18-13865
Location: Thousand Oaks, California
Position Type:Prof
Start Date / End Date: 10/01/2018 to 03/29/2019
Our client, a leading biopharmaceutical company is looking for a Sr. Drug Safety Associate. This is for an initial duration of 6 months and is located in Thousand Oaks, CA
 
Top Skill Sets:
  • Drug development and lifecycle management
  • Drug Safety data in clinical development and post-market settings
  • Knowledge of Safety database structure and conventions
  • Knowledge of MedDRA and other dictionaries used in pharmacovigilance
 
Job Summary:
  • Sr. Associate works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.
  • This person will also provide scientific and compliance expertise as needed to GPS.
  • Key Activities Applicable tasks may vary by product(s) assigned.
 
Responsible for the following:
  • Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports
  • Review of AE/SAEs from clinical trials as needed
 
Contributes under the direction of the Global PV Sr. Scientist or Lead to:
  • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
  • Review standard design of tables, figures, and listings for safety data from clinical studies
  • Participate in development of safety-related data collection forms for clinical studies
  • Attend study team meetings as requested or needed
  • Conduct signal detection, evaluation, and management
  • Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
  • Prepare safety assessment reports and other safety documents and regulatory responses
  • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
  • Participates in Safety Governance per client processes
  • Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
  • Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
  • Provides contents for risk management plans
  • Update strategy and content for regional risk management plans
  • Assist GSOs to oversee risk minimization activities including tracking of activities as needed
  • Evaluate risk minimization activity
  • Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
  • Support activities related to new drug applications and other regulatory filings
  • Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities Provide safety contents for filings
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.