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<h1>(post-marketing) Pharma EU-QPPV (f/m/d) Praha/Bratislava/Vienna/EU</h1><a>min. EUR 5.000,-- gross p.m.</a><a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=104105&amp;refererId=625" target="_blank">APPLY</a>Our client is an internationally active, well established, further growing Austrian pharma SME with an Rx portfolio in various indication areas including ophthalmology, ICU, CV, and some OTC products. The company is searching now for the management of the post-marketing PV/safety responsibilities of the group an internationally experienced EU-QPPV based in Czechia, Slovakia, Austria, or eventually another EU country.<h2>Responsibilities: </h2> 
<ul> 
 <li>Key functions are the formal EU-QPPV &amp; Head of PV Management roles with responsibility for a small team of local PV managers and as the contact person to local external PV partners and authorities</li> 
 <li>Responsibilities according to Regulation (EC) No 726/2004 Articles 23ff including the establishment and maintenance of the PV system (incl, rRMMs), the preparation of PV reports as defined by regulations, answering requests from health authorities, and providing health authorities with any other information relevant to product safety</li> 
 <li>Representation of the group at audits, inspections, and response processes to any relevant post-marketing PV matters, acting as point of contact for the regulatory authorities on a 24-hour basis and as the contact point for PV inspections</li> 
 <li>Expediting ICSR reporting and aggregate reports (PSURs, RMPs, PASS studies …) in relation to quality, focusing on accuracy, completeness, and timeliness</li> 
 <li>Safety databases management, training of personnel in relation to PV</li> 
 <li>Ensure together with RA the appropriate medical input to PV reports including ICSRs and PSURs as well as for the registration documents, providing the safety contribution to regulatory authority submissions</li> 
 <li>Management of (potential) AEs including the corresponding monitoring of the relevant literature in cooperation with local PV managers and external partners respectively</li> 
 <li>Safety assessments and drug safety reports for signals or other issues, e.g. product quality, or in response to health authority (HA) requests</li> 
 <li>Based on individual experience and qualification additional support as MA Manager for matters such as approval of marketing material, medical literature analysis/input for marketing et al and as MIO</li> 
</ul> 
<h2>Requirements:</h2> 
<ul> 
 <li>MD preferred or advanced science degree in Life Sciences is required</li> 
 <li>High level of experience and expertise in PV in the EU, including aspects of medical safety, ideally also as EU-QPPV or deputy EU-QPPV</li> 
 <li>Excellent knowledge of European regulatory requirements relating to PV</li> 
 <li>PV systems experience (covering compliance, databases, procedures, QA, training)</li> 
 <li>Experience with audits/inspections</li> 
 <li>Fluent English proficiency (C2), further EU language skills are an advantage</li> 
 <li>Highly reliable, communicative, entrepreneurial personality who is motivated to develop the PV system and stringently manage strategy and operation of all safety related tasks, issues, documentation, and reporting for a dynamic, internationally active pharma SME with flat hierarchies</li> 
</ul> 
<h2>The Offer:</h2> The company offers a fixed monthly gross salary at a minimum of EUR 5.000,-- with possible overpay depending on qualification, experience, and local standards and besides the regular respectively defined EU-QPPV post-marketing tasks an interesting role with the opportunity to participate as part of the HQ management team also actively in the strategic development of the company. 
 
<br>Please send your application including CV and motivation letter under Kennnummer 104&nbsp;105 preferably on our application portal <a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=104105&amp;refererId=625" target="_blank">ISG-Karriereportal</a> or per eMail to <a href="mailto:bewerbung.seligo@isg.com" target="_blank">bewerbung.seligo@isg.com</a>. 
<p>Visit us at <a href="https://www.isg.com/jobs/search" target="_blank">isg.com/jobs</a> - with our accurate job offers.</p><a href="https://www.isg.com" target="_blank"></a>ISG Personalmanagement GmbH 
<br> A-1010 Wien, Universitätsring 14 
<br> Dr. Roman Seligo, T: +43 1 512 35 05 
<br> @:<a href="mailto:bewerbung.seligo@isg.com" target="_blank"> bewerbung.seligo@isg.com</a>

ISG Personalmanagement GmbH

Wir sind die ISG

EU-QPPV (f/m/d)

<h1>Purchasing Manager (Southern Moravia))
<h2>Industrial production</h2></h1><a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=104043&amp;refererId=625" target="_blank">APPLY</a>
 
  Are you experienced in procurement within the industrial sector, interested in a diverse role, and capable of managing multiple tasks simultaneously? 
  Do you want to leverage your experience in a stable company, take responsibility for a dedicated agenda, and contribute to the success of a strong, international corporation? 
  If so, this managerial position offers an excellent opportunity for professional self-realization. 
  
Our client is a leading manufacturing company in the South Moravian region and a member of a global group of companies. To strengthen the on-site management team, we are seeking a new professional (m/f/d) for the role of: a Purchasing Manager.In this role, you will be responsible for the complete procurement agenda for a manufacturing plant near Brno, working closely with production, logistics, and the international headquarters.  Key Responsibilities: 
<ul> 
 <li>Lead the procurement department and ensure its effective operation.</li> 
 <li>Effectively lead, manage, motivate a team of purchasers.</li> 
 <li>Secure the supply of materials and services according to required criteria (quality, reliability, cost).</li> 
 <li>Source, evaluate, and develop suppliers.</li> 
 <li>Manage costs and adhere to the department’s budget.</li> 
 <li>Contribute to the strategic development of the company.</li> 
 <li>Handle complaints and optimize the supply chain.</li> 
</ul> Requirements: 
<ul> 
 <li>A successfully completed technical or economic education.</li> 
 <li>Several years of experience in a similar position within manufacturing.</li> 
 <li>Experience with ERP systems (SAP preferred) and proficiency in MS Office.</li> 
 <li>Ability to lead and motivate a team, with strong resilience to stress.</li> 
 <li>Strong communication and well-developed social skills.</li> 
 <li>Proficiency in Czech or Slovak and a very good command of English.</li> 
</ul> What do we offer? 
<ul> 
 <li>Opportunities for professional growth in a successful and dynamically growing industrial company.</li> 
 <li>Work in a friendly team with opportunities for self-realization.</li> 
 <li>An attractive salary and employee benefits - the annual income for the position can reach 80,000 - 100,000 EUR, depending on seniority and experience.</li> 
 <li>A comprehensive benefits package includes company car and a range of other benefits.</li> 
</ul> 
<br>If you are interested in this challenging position we are looking forward to receiving your comprehensive application (CV along with a short cover letter summarizing your qualifications for the position, your possible start date, and your remuneration expectations) for ref.no. 104,043 via email to "<a href="mailto:rene.prazak@isg.cz" target="_blank">rene.prazak@isg.cz</a>" or via our <a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=104043&amp;refererId=625" target="_blank">ISG career portal</a><a href="https://www.isg.com" target="_blank"></a>ISG Personalmanagement s.r.o. 
<br> U Prašné brány 1078/1, 110 00 Praha 1 
<br> Dipl. Ing René Pražák, Phone: +420 602 280 027 
<br> @:<a href="mailto:application.prazak@isg.com" target="_blank"> application.prazak@isg.com</a>

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