Drug Safety/Pharmacovigilance

Job Title: Sr Safety Specialist

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 the 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.

·        Mange 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.

RELATIONSHIPS

Reporting: Associate Director, Project Management

Managerial: Individual contributor

Other: Collaborates across functions and regions on required safety matters

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.