Trumpa antraštė: Drug safety specialist lithuan

Darbo sritis: Sveikatos apsauga

Profesija: Kita

Miestas: Vilnius

Tel.: +370 5 2125573

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Aprašymas

<table><tr> <td colspan="2" align="left" class="jobadCompanyName" itemprop="hiringOrganization" itemscope itemtype="http://schema.org/Organization"><B itemprop="name">Delta Executive Search & Consulting</td> </tr> <tr> <td colspan="2" class="jobadDescription" itemprop="description"><p style="text-align: justify;">Our Client is the Representative Office in Lithuania of a global innovative healthcare company that provides solutions to the evolving needs of patients worldwide.</p><p style="text-align: justify;"> The company is strengthening its team in Lithuania and currently looking for the</p></td> </tr> <tr> <td colspan="2" class="jobadPosition" align="left"><b itemprop="title">DRUG SAFETY SPECIALIST LITHUANIA</td> </tr> <tr> <td colspan="2" class="jobadDescription" itemprop="description"><p style="text-align: justify;">to support management of DS&E operational processes in ensuring compliance with company global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of the company marketed and investigational products.</p><p><strong>Main functions:</strong></p><ol> <li style="text-align: justify;">Manage collection, processing, documentation, reporting and follow-up of all serious adverse events (SAE) reports for all company products from clinical trials, and all adverse events from Patient Oriented Programs, post-marketing studies (PMS), registries, and all Spontaneous Reports (SR) occurred in Lithuania.</li> <li style="text-align: justify;">Transcribe, translate and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from Patient Oriented Programs, post-marketing studies (PMS), registries and all Spontaneous Reports) from source documents occurred in Lithuania onto safety systems accurately and consistently with emphasis on timeliness and quality.</li> <li style="text-align: justify;">Record and track receipts, submissions and distributions of SAEs, SRs, local SUSARs, Periodic Safety Report Updates (PSUR) and Development Safety Update Report (DSUR) in cooperation with relevant departments.</li> <li style="text-align: justify;">Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, domestic SUSAR, PSUR, Biannual SUSAR Listing, DSUR) occurred in Lithuania to Local Health Authorities (LHA) and/or clinical operations in cooperation with other departments.</li> <li style="text-align: justify;">Work with other local/global PVO associates to ensure accurate evaluation of safety data.</li> <li style="text-align: justify;">Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and third party contractor, if applicable.</li> <li style="text-align: justify;">Survey and monitor national pharmacovigilance regulations and provide update to global PVO organization.</li> <li style="text-align: justify;">Develop, update and implement local procedures to ensure compliance with PVO global    procedures and national requirements.</li> <li style="text-align: justify;">Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.</li> <li style="text-align: justify;">Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.</li> <li style="text-align: justify;">Management and maintenance of all relevant PVO databases.</li> <li style="text-align: justify;">Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.</li> <li style="text-align: justify;">Develop and update training materials for pharmacovigilance and ensure training of CPO associates on relevant PVO procedures for AE reporting, including field force and third party contractor, if applicable.</li> <li style="text-align: justify;">Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.</li> <li style="text-align: justify;">Manage and maintain efficient PVO filing and archive system.</li> <li style="text-align: justify;">Acts as DSR Deputy: functional (in terms of responsibility for PV system) and operational (in terms of managing the DS&E Team), etc.</li></ol><p><strong>Requirements for the candidates</strong>:</p><ul> <li>A degree in pharmacy, health discipline or life sciences</li> <li>Fluent in English (both written and verbal)</li> <li>Good working knowledge of Lithuanian</li> <li>Knowledge of other languages (beneficial)</li> <li>Knowledge of national and international regulations for pharmacovigilance</li> <li>Knowledge of pharmacological and medical terminology</li> <li>Excellent communication, interpersonal and negotiation skills</li> <li>Orientation to detail</li> <li>Quality and focus oriented</li> <li>Advanced Computer skills.</li></ul><p style="text-align: justify;"><strong>The company offers</strong> a dynamic and challenging work environment, a friendly and professional team and opportunity for personal growth.</p><p><strong>To apply,</strong> please send your CV and motivation letter, indicating position to:</p><p><strong>Delta Executive Search & Consulting</strong></p><p><strong><a href="mailto:lina.kalinauskaite@executivesearch.lt">lina.kalinauskaite</a></strong><strong>@executivesearch.lt</strong></p><p>Confidentiality is guaranteed. Only successful candidates will be notified.</p><p> </p></td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Education required  <span itemprop="educationRequirements">Higher education (bachelor)</span></td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Languages required  English</td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Working time  <span itemprop="workHours">Full-time work</span></td> </tr> <tr id="locationrow"> <td colspan="2" class="jobadSingleLine">Location  <span itemprop="jobLocation">Vilnius</span></td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Position  Specialist</td> </tr> <tr> <td colspan="2" class="jobadContact">Contact information:</td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Contact person  Lina Kalinauskaite</td> </tr> <tr> <td colspan="2" class="jobadSingleLine">E-mail  <a href="mailto: lina.kalinauskaite@executivesearch.lt">lina.kalinauskaite@executivesearch.lt</a></td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Address  <span itemprop="jobLocation">Mėsinių g. 5, LT-01133 Vilnius, Vilniaus</span></td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Telephone  8 5 2125573</td> </tr> <tr> <td colspan="2" class="jobadSingleLine">Homepage  <a href="http://executivesearch.lt" target="_blank">http://executivesearch.lt</a></td> </tr></table><br />Prašytume nurodyti skelbimo numerį, kai kreipiates!<br />CVO-647225-LT

Kita informacija

• Skelbimas atnaujintas: 2015.11.14 00:37
• Skelbimas įdėtas: 2015.11.10 00:18
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