Senior Manager, Safety Science in Summit, NJ at APEX Systems

Date Posted: 1/16/2020

Job Snapshot

Job Description

Job #:  1027419


Sr. Manager, Trial Safety Science
General Responsibilities
  • Provides support in activities relating to monitoring and management of Product's emerging safety profile
  • Supports the logistics of Safety Management Team /Product Safety Review Meeting, maintains roster, calendar, and minutes/communication
  • Contributes to signal detection activities by supporting review and synthesis of key safety information; Contributes to signal evaluation and tracking
  • Supports 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 for Product Quality issue and inquiries from external department. 
  • 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 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 
  • Generates report form, pregnancy report form, completion guidelines for trial-related activities
  • Coordinates the management and preparation for preparation, documentation, and logistical support
  • May review study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs, and contribute to the safety strategy.

Compound Level Safety Support
  • May contribute to the content of Safety Reports 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 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 investigator and Queries
  • Supports various process improvement and cross-functional initiatives for both Safety Science, which may include input to the development and periodic update of SOP's 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

Requirements:
  • Pharmacy/Nursing degree (PharmD, RN)
  • Must have 4-6 years of relevant pharmaceutical industry experience
  • Previous experience in Safety or Clinical Development or Operations
  • Review of protocols
  • Clinical Trial experience

Please send all resumes to togele@apexsystems.com for consideration.
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.