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Snr Manager Drug Safety Science

San Diego Metro Area, CA

Posted: 03/01/2019 Job Type: Scientific Job Number: JN -032019-23827
  • Snr Manager Drug Safety
  • Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience
    Relevant Industry Experience = At least 4-6 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.
    Drug Safety Experience = 2-4 yrs
  • Provides support to activities relating to monitoring and management of Product's emerging safety profile
    Supports the logistics of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and minutes/communication
    May contribute to preparation of materials (Slides, etc.) in preparation of CSC meetings
    Contributes to signal detection activities by supporting review and synthesis of key safety information; Contributes to signal evaluation and tracking
    Supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the product s benefit/risk profile
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