EEA QPPV Qualified Person for Pharmacovigilance

				Responsibilities:

* Act as Qualified Person Responsible for Pharmacovigilance within EEA.
* Legally responsible for and has oversight of all pharmacovigilance activities within EEA for marketed drugs for (or on behalf of) Marketing Authorization Holder (MAH);
* Continuously and permanently available to deal with issues involving the safety of the marketed drugs and ensures that the Deputy QPPV is available in case of her/his absence.
* Maintain awareness of all products related safety issues for marketed products and products where Marketing Authorization Applications has been submitted in the EEA.
* Ensure existence of adequate processes including SOPs for monitoring post-marketing medicinal product safety.
* Ensure existence of updated 'Pharmacovigilance System Master File' (PSMF) such that it is accurate and maintained to remain fully compliant.
* Familiar with the current safety profile of marketed medicinal products in the EEA for marketed drugs for MAH;
* Responsible for compliance of pharmacovigilance system including expedited reporting and aggregate reports.
* Aware of all partnering relationships involving marketed products in the EEA.
* Ensure that the Deputy QPPV is fully informed about current drug safety issues.
* Ensure the compilation and adequacy of all periodic aggregate safety reports and Risk Management Plans (RMP).
* Responsible for the signal detection process in conjunction with the medical monitor.
* Ensure regular communication with MAH and local safety responsible people regarding safety issues; and
* Work with the Clinical Quality Assurance group to support regular PV and Risk Management audits of the PV group and partners, as well as attend regulatory authority inspections, as applicable.

Qualifications:

* Medical doctor, PhD, Life Science degree and health professionals with extensive PV experience (5 + years in Pharmacovigilance).
* Understands and maintains knowledge of PV regulations and guidelines.
* Good level of PV experience ideally in leading safety affiliate roles and additional experience in headquarters roles desirable.
* Demonstrated experience of proactively driving a variety of tasks and projects and delegating to team members.
* Excellent organizational and communication skills. Demonstrated persuasion and influence skills.
* Proven ability to deal with diversity, ambiguity, and multi-tasking.
* Ability to process information, analyze data and reach conclusions based on sound reasoning; and
* Excellent Word, Excel and Power Point skills.
			

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