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<p>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.</p><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><p> 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.  </p>  <p>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;jsessionid=ebc1b19dca949bc5b5192993166f?inseratnummer=104105&amp;refererId=372" target="_blank">ISG-Karriereportal</a> or per eMail to <a href="mailto:bewerbung.seligo@isg.com" target="_blank">bewerbung.seligo@isg.com</a>.  </p><p>Visit us at <a href="https://www.isg.com/jobs/search" target="_blank">isg.com/jobs</a> - with our accurate job offers.</p>

ISG Personalmanagement GmbH

EU-QPPV (f/m/d)

<p>Our client is an internationally active, well established, further growing Austrian pharma company with an Rx portfolio in various indication areas including ophthalmology, ICU, and some OTC products. The company is searching now for an experienced pharma manager with a good network to hospitals and other relevant market contacts as Country Manager and Managing Director to manage the Czech sales team and subsidiary of the Group.</p><h3>Responsibilities:</h3>  <ul>   <li>In this role you have the overall responsibility as Country Manager and Managing Director of the Czech s.r.o. subsidiary of the Group. You will manage a small sales rep team and be active with key clients personally in parallel – a key target is to further grow the business and the local organization alongside<br></li>   <li>The company owns a distinctive brand portfolio in a number of indication areas including ophthalmology, ICU, and some OTC products, thus covering the respective resident doctors (physicians) as well as hospitals (tender business), and pharmacies<br></li>   <li>A substantial number of new launches and a significant relaunch are scheduled for 2024 and 2025 as well as a further pipeline for the following years, offering USPs and good marketing arguments<br></li>   <li>The new Managing Director will focus on new launches, relaunches, and increasing sales and profits, whilst HQ services cover supply chain, QM, RA, finance, and international marketing support<br></li>   <li>Key focus of the role is to further develop respectively grow the business and organization, leveraging own experience and relevant sales and business networks as well as the positioning of specific product USPs, and a new sales team approach – with central functions’ support from the international HQ<br></li>   <li>Full P&amp;L responsibility and direct reporting line to the group CEO in the international HQ in Austria</li>  </ul>  <h3>Requirements:</h3>  <ul>   <li>A higher university degree in medicine, pharma, biotech, or similar is required<br></li>   <li>10+ years’ experience in pharma M&amp;S in Czechia is a must, hereof min. 4 years in a leadership role such as Sales Manager/Director – experience as Country Manager and/or MD is an advantage<br></li>   <li>Strong business acumen with proven credentials/market successes on the Czech market from prior pharma M&amp;S or Country Manager roles<br></li>   <li>Relevant personal networks to hospitals, KOLs, and other relevant market players, business acumen and contacts to “be the first” to take advantage of market opportunities from trends and/or legal (e.g., reimbursement) changes, experience, and ability to position and sell products based on qualitative arguments rather than on rebates<br></li>   <li>Good MS Office user skills<br></li>   <li>Czech language skills on a native level (C2) and fluent English proficiency (C1)<br></li>   <li>Active drivers’ license and high mobility within Czechia (min. 40%)<br></li>   <li>Entrepreneurial, dynamic, flexible, self- and result-driven, self-responsible, hands-on spirit and highly trustful, active, and motivational leadership personality, intrinsically motivating and driven to very actively further grow the business for the Group in Czechia</li>  </ul>  <h3>The Offer:</h3><p> The company offers a state-of-the-art MD package including a fixed gross monthly salary at minimum EUR 7.000,--, negotiable based on experience and credentials, plus a bonus and a company car, as well as a long-term perspective and the opportunity to step into an independent role and an already established business with significant growth potential.  </p><p> Please send your application including CV and motivation letter under the position number 103.401 <a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf;jsessionid=883a12f586f6d741ff8740f7ec09?inseratnummer=103401&amp;refererId=372" target="_blank">ISG-Karriereportal</a> to our responsible recruiting manager Dr. Roman Seligo at <a href="mailto:roman.seligo@isg.com" target="_blank">roman.seligo@isg.com</a>.</p>

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