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

Date Posted: 2/14/2020

Job Snapshot

Job Description

Job #:  1048733


Senior Manager, Safety Science:
Key Responsibilities: 
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

Requirements:
  • Pharmacy/Nursing (BSN, MS, PharmD) degree
  • At least 4 years of relevant pharmaceutical industry experience
  • Previous experience in Safety or Clinical Development or Operations
  • 2-4 years of experience within Drug Safety
  • Decision-Making & Change Agility
  • Communication/Writing
  • Time Management & Prioritization
  • Results-Drive
  • Self-Awareness & Perspective

 
 
 
 
 
 
 
 
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.