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

Wi80YnRFekI0Rlg0cnF5L1pTbU9YdW1OU2c9PQ==
  • 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

Link Up Overseas

Virtual Assistant, Data Entry / Full Time Job at Link Up Overseas

About the job Virtual Assistant, Data Entry / Full TimeData Entry Assistant - Entry Level (Remote)Areyou a detail-oriented individual with excellent organizational skills?Are you looking for an exciting opportunity to kickstart your career indata entry? If so,... 

Janus Research Group

Senior Cyber Security Engineer Job at Janus Research Group

 ...verify, before applying, that you meet the minimum requirements of the position.JANUS Research Group is seeking a Senior Cyber Security Engineer.Job Responsibilities:Analyze and define security requirements for Multilevel Security (MLS) issues.Design, develop, engineer... 

UHS

MUSIC/ART THERAPIST Job at UHS

 ...Degree in Expressive Therapy, Music Therapy, Art Therapy, or Dance/Movement Therapy....  ...Dance/Movement Therapy (R-DMT), Recreational Therapist (RT) required. State licensure required,...  ...program director/nurse coordinator. Assists in ordering and maintaining the expressive... 

Alaska State Gov

Office Assistant 3 Job at Alaska State Gov

Alaska State Gov - Environmental Conservation [Administrative Assistant / Receptionist] As an Office Assistant at the State of Alaska, you'll: Process Emergency Firefighter hiring packets and payroll; Assist the Travel Desk Coordinator and arrange air and/or ground transportation... 

WCTractor

Service Writer Job at WCTractor

 ...Holland - Sealy, TX Position Type Full Time Education Level High School Travel Percentage Negligible Job Shift Day Job Category Customer Service Service Writer Job Description Service Writer Overview WCTractor is an established...