Senior Manager, Clinical Safety Science, Summit, NJ

Senior Manager, Clinical Safety Science, Summit, NJ

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 

Qualifications/Experience 

  • 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. 
  • 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

For immediate consideration, apply today! Questions? Call Toni at 714.454.8252 OR email at toni.marr@kellyscientific.com

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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