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Trial safety manager

Title: Trail Safety Manager

Location: New Jersey

Duration: 6-months

Responsibilities:

  • Provides support to the Lead Product Safety Physician (LPSP) in activities relating to monitoring and management of Product's emerging safety profile
  • Contributes to signal detection activities by supporting review and synthesis of key safety information; Contributes to signal evaluation and tracking
  • Supports/May lead the strategy for surveillance activities, as appropriate
  • Participates in ongoing SAE reconciliation between the safety and clinical databases
  • Completes study-level activities generation of Case Management Work aids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF
  • Generates SAE report form, pregnancy report form, completion guidelines for trial-related activities
  • May contribute to the content of Aggregate Safety Reports (PSUR/DSUR) and Investigator Brochures in accordance with regulatory requirements and standard operating procedures
  • Obtains integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician for a compound

Requirements:

  • Education: Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience
  • At least 4-6 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required
  • 2-4 yrs of Drug Safety Experience

Sthree US is acting as an Employment Business in relation to this vacancy.