Associate Marketed Project Safety Director - Sponsor Dedicated
Employer · IQVIA
Other health professional
Specialist doctor
Health services managerFull-timeBudapest
The Associate Marketed Product Safety director is intended to serve as a fully sponsor dedicated deputy QPPV role. The deputy QPPV receives delegation of certain tasks and activities in line with the overall QPPV responsibilities and should be able to work independently and with authority.
Tasks
- Assist the QPPV in analysing, anticipating, and communicating the impact of emerging regulations on the company pharmacovigilance processes and product portfolio management for assigned marketed products.
- Contribute to the construction of the pharmacovigilance regulatory guidance.
- Advise and guide the functions involved to help ensure that the pharmacovigilance system required by EU regulations and associated guidance is properly implemented at the client.
- Ensure and verify that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system under the QPPV's responsibility.
- Evaluate risks and communicate global impact issues to the QPPV and recommend appropriate action plans.
- Participate in mandatory client governance meetings.
- Assist in developing the client reputation at health authority level.
- Review and provide advice in management of product-related safety matters, that could impact patient health in relation to the benefit-risk of products.
- Provide routine updates on product related issues to the QPPV on a periodic basis.
- Timely review and/or approval of documents intended for submissions to regulatory authorities.
- Other tasks assigned in line with overall QPPV role.