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Senior Manager
Ref No.: 19-16278
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Senior Manager in Summit, NJ with one of our top client.
Job Title: Senior Manager
Job Id: 19-16278
Location: Summit, NJ 07901
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Job Description
  • 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
  • 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
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 andWork 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 
Qualifications/Experience
  • Education 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 (SENIOR MANAGER) OR 6-8 years (ASSOCIATE DIRECTOR) of relevant pharmaceutical industry experience.
  • Previous experience in Safety or Clinical Development or Operations is required.
  • Drug Safety Experience 2-4 yrs. (SENIOR MANAGER); at least 4 years (ASSOCIATE DIRECTOR) 
Behaviors/Competencies
  • Decision-Making & Change Agility
  • Communication/Writing
  • Time Management & Prioritization
  • Results-Drive
  • Self-Awareness & Perspective 
Contact
Bhavani Sangmesh
Direct: (732) 272.0325 | Bhavani.S@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com