Global PV SDEA Technical Specialist in Bridgewater, NJ

The primary role and function of the Global PV SDEA Technical Specialist is to provide support to the SDEA team for selected activities related to the planning, set up, and maintenance of global SDEA by being primarily responsible for

• maintaining up-to-date contact information for safety data exchange with Business Partners
• supporting the finalization and roll out communication of new/ revised/ terminated SDEA
• ensuring data entry and filing in the relevant SDEA repository(ies)
• being the key expert user for and providing support on SDEA repository
• managing the extraction of monthly reports from SDEA repository with prior checking of relevant repository update by SDEA managers
• Interface with Business Partners and GPE operational teams/ Affiliates to maintain contact information accurate all year long, including update of SDEA repository;
• Participate in/ coordinate the annual contact verification in liaison with SDEA team and/ or vendor(s), as well as Business Partners;
• Maintain the related Quality Document describing SDEA contacts management.
• Finalize global SDEA in its executive version (SDEA quality control);
• Ensure global SDEA full signatory process (internal & external entities);
• Ensure SDEA tracking, filing (including quality control)
• Ensure communication on global SDEAs so that they are implemented on time;
• Maintain the related Quality Document describing the SDEA administrative management process
• Prepare global SDEA summaries with SDEA Manager’s support (as needed), Maintain them in dedicated repository(ies)
• Assist the SDEA team with the management of the generic mailbox
• Support the preparation and conduct of SDEA meetings (team meetings, SDEA Review Committee, PPCRM, ad hoc meetings…), e.g. preparation of meeting agenda, minutes, presentations…
• Support the preparation/ conduct of audit and inspections of SDEA activities
• Support the local SDEA oversight for GPE management and QPPV, in collaboration with SDEA Manager(s) (e.g. contribute to the Quality Control of the information provided by LPCs..).

Skills:

      • Good knowledge of Pharmacovigilance regulatory environment
      • Qualifying to represent client GPE towards other Companies / Departments / Affiliates
      • Good knowledge of Microsoft Office (Word, Excel, PowerPoint)
      • Ability to work with databases (BALi, e-rooms)/ with sharepoint
      • Creativity to propose/create/supervise appropriate tools to support business activity
      • Quality-oriented and well-organized / proactive reporting Quality oriented and well-organized/ proactive reporting
      • Writing quality documents

Experience:

• years of experience in Pharmacovigilance in an International environment. 
• Additional experience in Legal department, Regulatory Affairs or Clinical studies as well as experience of work in interface with external companies/partners would be a plus.

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