Senior Drug Safety Specialist, GPIO

Job Description Summary

The Drug Safety Specialist, GPIO, is a key member of the Global Pharmacovigilance Intelligence Office (GPIO) who is contributing to the success of Parexel Global Safety Reporting Group (GPRG) and other departments by providing safety reporting related regulatory intelligence for the business. The Drug Safety Specialist GPIO, works within the GPIO team to deliver quality output for our internal and external clients, improve processes and enhance GPIO services offered.

Job Description

•Responsible for regular safety reporting related regulatory intelligence research, country reviews and quality control procedures, including documenting, communication said changes and updates as per procedures

• Accountable for country safety requirement update reviews for assigned countries and act as back for other team members, as required

• Liaise and communicate with ethics review boards and committees, regulatory agencies, local safety contacts etc. for safety regulatory updates relevant to safety reporting

• Responsible for quality control of deliverables, updates and documentation as requested

• Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs

•Collaborating with and assisting the Global Pharmacovigilance Intelligence Office (GPIO) team in operational day-to-day activities

•Leading and participating in functional internal and external team meetings, act as a point of contact with selected clients, as needed.

• Ensuring that work completed meets the requirements as in-Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings for regulatory intelligence for both internal and external clients

• Providing functional expertise/oversight of regulatory requirements and for PV Operations staff (both pre and post-marketing setting)

• Prepare for, participate and respond to internal/external audits/inspections, as needed

#LI-REMOTE