Job Details

  • Title: Trial Safety Manager
  • Code: RCI-9088
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 02/14/2020
  • Duration: 6 Months
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  Job Description

Key Responsibilities will include, but are not limited to, the following:

General Responsibilities:

  • Provides support to LPSP in 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
  • Provides support to LPSPs for Product Quality issue and inquiries from external department (e.g. Legal, clinical, RA, etc.)
  • May provide input and support safety publication strategy
Trial Safety Support:
  • Leads execution of all operational safety-related clinical trial activities, and may serve as the Lead Safety Scientist for a compound
  • 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
  • Coordinates the management and preparation for DMC preparation, documentation, and logistical support
  • May review study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]), and contribute to the safety strategy and key safety messages for the CSR
Compound Level Safety Support:
  • 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
  • May support the lead product safety physician with the management of the product’s benefit/risk profile
Post-marketing Support:
  • May contribute to development of signal detection strategy with consideration for integrating quantitative data mining methods and qualitative approaches
  • May contribute in development of risk mitigation strategies by providing key safety findings and/or supportive data
  • May contribute to Safety Topic Review development by authoring certain sections
  • Contributes to ad-hoc regulatory safety requests preparation by obtaining data from various sources to assist the Lead Product Safety Physician in determining the impact of the safety issue on the product’s benefit/risk profile
  • Contributes to the content of aggregate safety reports (PSUR/DSUR), Risk Management Plans, and Events of Interest Surveillance Documents
  • Contributes to safety labeling activities for assigned products
  • Performs literature review and QC
Departmental Activities:
  • Supports preparation for regulatory inspections with evaluation of current processes and documentation
  • Liaises with all TA staff and maintain an effective and collaborative product safety team
  • Supports hiring, orientation, management, mentorship, and development of staff Cross-Functional Activities
  • Provides safety training to site and study personnel, and responds to ad hoc Investigator / IRB / EC Queries
  • Supports various process improvement and cross-functional initiatives for both Safety Science and GDRSM, which may include input to the development and periodic update of SOPs and Work Practices
  • Interacts with key line functions in support of safety activities between Safety Science and clinical R&D, Biostatistics, Data Management, Trial Management, Medical Affairs, or Safety Information Management
Key Relationships:
  • Department staff, peers and management
  • Lead Product Safety Physicians
  • Clinical Operations
  • Data Management
  • Clinical Research Scientists
  • Medical Writing
  • Case Management / LDSO
  • Global Medical Affairs
  • Regulatory Affairs
  • Clinical Quality Assurance Governance
  • Participate and/or provide input to materials and strategies at meetings including but not limited to:
    • SMT - Safety Management Teams
    • DMC - Data Monitoring Committees – internal or external
    • Clinical Study Team

  • 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
  • Managerial Experience: N/A
Key Leadership Behaviors/Competencies:
  • Decision-Making & Change Agility
  • Communication/Writing
  • Time Management & Prioritization
  • Results-Drive
  • Self-Awareness & Perspective