EEA QPPV Qualified Person for Pharmacovigilance

Job Summary

Our postmarketing pharmacovigilance activities are growing rapidly within the European Economic Area (EEA) , and we are currently seeking a full-time, office-based EEA Qualified Person for Pharmacovigilance to join our team to be based at our growing office in Munich . This position plays a key role in the pharmacovigilance process at Medpace, and will involve working in a team to accomplish tasks and projects that are instrumental to the company’s success.

If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

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.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility