EU-QPPV Team Lead Position in Pharmaceuticals
vor 2 Wochen
The ISG Personalmanagement GmbH, a dynamic and internationally active Austrian pharma SME, is seeking a highly experienced EU-QPPV to lead their post-marketing PV/safety responsibilities. This role offers an exciting opportunity to participate in the strategic development of the company as part of the HQ management team.
As the formal EU-QPPV & Head of PV Management, you will be responsible for managing a small team of local PV managers, interacting with external PV partners and authorities, and ensuring compliance with European regulatory requirements. Key functions include the establishment and maintenance of the PV system, preparation of PV reports, and representation of the group at audits, inspections, and response processes to post-marketing PV matters.
Your duties will also include expediting ICSR reporting and aggregate reports, safety databases management, training of personnel, and providing medical input to PV reports. Additionally, you will manage (potential) AEs, perform safety assessments, and drug safety reports for signals or other issues. Your expertise in PV systems, experience with audits/inspections, and knowledge of European regulatory requirements are essential for this role.
The ideal candidate should possess a MD or advanced science degree in Life Sciences, have high-level experience and expertise in PV in the EU, and excellent communication skills. Fluent English proficiency (C2) is required, with further EU language skills being an advantage.
This position comes with a competitive fixed monthly gross salary of €5,000,-- with possible overpay depending on qualification, experience, and local standards. The company offers a dynamic work environment with flat hierarchies and opportunities for professional growth.
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