Senior Drug Safety Associate (JP4727)

Location: Thousand Oaks, ca
Date Posted: 09-14-2018
Job Title:  Senior Drug Safety Associate (JP4727)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  GPS – TAS (Oncology)
Duration: 5+ months (likely extensions)
 
3Key Consulting Inc. is recruiting for a Senior Drug Safety Associate with 3 - 5 years’ experience in drug development and lifecycle management, drug safety, drug safety databases, MedDRA and other dictionaries used in pharmacovigilance for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
The Drug Safety Associate works with the Therapeutic Safety Teams in assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.  Key activities and applicable tasks may vary by product(s) assigned. 
 
  • 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 Amgen 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.
 
Top Must-Have 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
 
Day to Day Responsibilities
  • Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports.
  • Works with affiliates and other internal Amgen partners regarding deliverables.
  • 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.
    • eview standard design of tables, figures, and listings for safety data from clinical studies.
 
Why This Position Is Open:
Need additional support for the team.
 
Red Flags:
Food safety, health hazard and safety, case processing only, out of country, location outside of time zone, unable to work on-site
 
Interview process:
Phone followed by possible in-person interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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