EU-QPPV (f/m/d) - Post-Marketing Pharmaceutical Expert

vor 1 Woche


Vienna, Österreich ISG Personalmanagement GmbH Vollzeit
Job Title: EU-QPPV (f/m/d) - Post-Marketing Pharmaceutical Expert

Job Description: We are seeking an experienced EU-QPPV to manage the post-marketing PV/safety responsibilities of our internationally active, well-established pharma SME.

Responsibilities:

* Formal EU-QPPV & Head of PV Management roles with responsibility for a small team of local PV managers
* Representation of the group at audits, inspections, and response processes to any relevant post-marketing PV matters
* Expediting ICSR reporting and aggregate reports (PSURs, RMPs, PASS studies ...) in relation to quality
* Safety databases management, training of personnel in relation to PV
* Ensure together with RA the appropriate medical input to PV reports including ICSRs and PSURs as well as for the registration documents
* Management of (potential) AEs including the corresponding monitoring of the relevant literature in cooperation with local PV managers and external partners respectively
* Safety assessments and drug safety reports for signals or other issues

Requirements:

* MD preferred or advanced science degree in Life Sciences is required
* High level of experience and expertise in PV in the EU, including aspects of medical safety
* Excellent knowledge of European regulatory requirements relating to PV
* PV systems experience (covering compliance, databases, procedures, QA, training)
* Experience with audits/inspections
* Fluent English proficiency (C2), further EU language skills are an advantage

The Offer:

We offer a fixed monthly gross salary at a minimum of EUR 5.000,-- with possible overpay depending on qualification, experience, and local standards.

How to Apply: Please send your application including CV and motivation letter under Kennnummer 104 105 preferably on our application portal ISG-Karriereportal or per eMail to bewerbung.seligo@isg.com.

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