Senior Safety Specialist Job at System One, Jersey City, NJ

eGNaSWlzWG1tOEFrTG9YbnA3c1V4ZVlWN1E9PQ==
  • System One
  • Jersey City, NJ

Job Description

Job Title:  Sr Safety Specialist 

Pay Rate: $35hr – 45hr

Hours Per Week: 35

Location: Remote or hybrid at Jersey City, NJ

Contract Length: 6 months (Temporary Contractor)
Supervisor :      Associate Director, Project Management



Manager Notes:  Seeking someone with project management experience and has working knowledge of Drug Safety, MS Project and MS Excel.

POSITION OVERVIEW/SUMMARY
The Senior Drug Safety Specialist / Safety Manager, Project Management is responsible for providing support to regional and global Drug Safety Pharmacovigilance (PV) projects. Projects include global marketing application and clinical development programs. Responsibilities include supporting company’s marketing application strategies, development of safety project timelines, and ensuring deliverables are achieved. Will be responsible for scheduling and facilitating meetings and developing minutes. Will assist in the vendor selection and assessment, budget review and invoice processing. The position is located within the specialized Drug Safety Project Management Office (PMO).

KEY RESPONSIBILITIES
  • Manage and support Global Safety Teams (GST) as a project manager with responsibility to track pharmacovigilance activities/safety signal management activities. Maintaining GST membership and providing member access right to information, monitor progress of global safety signal detection and management plans (SSDMPs) for global developmental and marketed products.
  • Manage and track safety membership for Early and Integrated Development Teams (EDT/IDT) and Clinical Operation Teams (COT).
  • Support clinical drug development project manager per global product and indication. Manage safety timelines, drive timely completion of tasks/deliverables, and resource management for global products with active clinical trials.
  • Ensure meeting productivity and advance decision-making effectively through the application of strong skillsets in strategic thinking, influence, leadership, relationship building, proactive-ness, curiosity and active engagement.
  • Support clinical drug development project manager with global marketing applications (e.g. US FDA NDA, HC NDS, EU MAA) timelines and drive timely completion of safety tasks/deliverables (e.g. M2.7.4 Summary of Clinical Safety) assigning resources (e.g. medical writing, QC review) as needed.
  • Support strategic planning for the Drug Safety partner with Sourcing Department. Manage review of proposals (RFI/RFP), budgets and develop evaluation of services and vendors.
  • Manage and track CRO/Vendor/Consultant contracts, Statement of Work (SOWs) based on the contract term/expiration, manage the renewal partnering with key Drug Safety stakeholders and Sourcing. Contribute to the management of vendor services and deliverables.
  • Works with Drug Safety key stakeholders to improve business processes, CRO/Vendor/Consultant services to enhance business efficiency.
  • Develop Purchase Orders (POs) for contracted service to provide billing. Manage and review of invoices for services rendered by CROs/Vendors/Consultants providing Drug Safety services. Perform follow up and resolution to invoices and services.
  • Maintains working knowledge of relevant regulations, company policies and assigned products.
  • Performs other departmental duties as assigned.
QUALIFICATIONS
Education :       
  • Minimum B.A./B.S. in life/health sciences or related field.
  • PMP certification is preferred
Professional Experience :
  • Minimum 5 years of pharmaceutical industry experience in Drug Safety, Medical Affairs, Clinical Development, or pharmaceutical industry
  • Experience with Clinical Drug Development and Phase 1-4 clinical trials and Post Marketing Safety Surveillance
  • Experience in Clinical Trial Management and Clinical Operation/Management Teams
  • Experience with vendor management development of request for information and proposals (RFI/RFP) proposals, budgets, and invoicing
Knowledge and Skills :
  • Strong analytical skills and insight to solve various types of business problems
  • Strong organizational skills including attention to detail along with problem-solving, flexibility, and conflict-resolution abilities
  • Strong verbal and written communication and presentation skills, including experience with multicultural audiences. 
  • Experience managing multiple projects, often complex in nature and with both internal cross-functional and external stakeholders under short timelines.
  • Working knowledge of Food and Drug Administration Regulations, including but not limited to: 21 CFR, 312 and 314, GCP, and ICH.
  • Working knowledge of Drug Safety databases, such as ARGUS, is desirable
  • Working knowledge of Microsoft Project, Word, PowerPoint, and Excel.

Job Tags

Contract work, Temporary work, For contractors, Remote job,

Similar Jobs

Express Oil Change & Tire Engineers

Automotive Service Manager Job at Express Oil Change & Tire Engineers

 ...Oil Change & Tire Engineers is one of the leading automotive service providers in the nation with over300 locations across 19states. We employ...  ...growth. Job Description The Automotive Service Manager, reporting to the Store Manager, will be responsible for... 

Kelly BMW

Service Advisor Job at Kelly BMW

As a Service Advisor, you will own our customers experience in the service lane. You are the first point of contact with our customers...  ...Dealership: A strong community is all about its people, and here at Kelly BMW we staff our building with good, kind people who go above... 

Northwest New Mexico Council of Governments

Economic Development Program Manager Job at Northwest New Mexico Council of Governments

 ...We're only hiring change agents looking to make an impact on the world. Ever wanted to build a Economic Development District (EDD) from the ground-up and operate it in your leadership style? The Northwest NM Council of Governments is looking to hire an EDD Manager,... 

CarRentalRate.com

Work-from-Home Research Travel Assistant Job at CarRentalRate.com

 ...Job Title:Work-from-Home Research Travel Assistant Location: Remote Company Overview: At Car Rental Rate, we specialize in providing exceptional car rental services for travelers seeking unforgettable experiences in the worlds most beautiful tropical destinations... 

Cushman & Wakefield

Welding technician Job at Cushman & Wakefield

 ...Job Title Welding Pipefitting Technician Job Description Summary Welding & Pipefitting Technician Who Are...  ...supervision and follow-up. Tasks also include layout and fabrication of new and replacement piping systems, as well as installation...