About this role
<p style="margin:0.0in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%">Job objective:</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Process and document relevant information regarding drug safety.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Scientific consultancy regarding drug safety and pharmacovigilance, including the preparation and continuous updating of reports on the risk-benefit balance of human medicinal products (Periodic Safety Update Reports-PSURs, Addendums to Clinical Overviews, Risk Management Plans-RMP).</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Collection, documentation, and evaluation of reports on drug risks and coordination of essential actions in accordance with good pharmacovigilance practices and other relevant legislative acts.</span></li> </ul> <p style="margin:0.0in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%">Responsibilities:</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Prepare and update reports on drug safety (Periodic Safety Update Reports – PSURs, Periodic Benefit-Risk Evaluation Report – PBRERs) periodically.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Investigate medical literature databases to collect and evaluate relevant articles regarding adverse effects relevant for creating PSURs.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Investigate reports related to potential/suspected risks before the marketing authorization is granted, spontaneous case reports after marketing authorization has been issued; ongoing checks of safety reports received by the company for serial cases. Evaluations are based on research of publications in the scientific literature.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Collect additional information regarding drug risks in the case of spontaneous or external case reports (e.g., from authorities) and prepare assessments for the safety reports of the drug.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Collect, evaluate, and document reports related to drug safety (adverse reactions, pharmaceutical technical defects) in centralized databases.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Maintain the necessary correspondence for completing documents containing reference information for the company's portfolio products, with data related to drug safety - with internal departments.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Support organizational activities in taking measures related to drug safety (such as batch recalls, risk minimization activities). </span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Database queries, preparation of statistics, presentations, and other reporting.</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Perform individual tasks for the smooth running of team work, as needed.</span></li> </ul> <p style="margin:0.0in 0.0in 0.0in 0.25in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%">Your profile:</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Higher studies in pharmaceuticals or medicine; bachelor degree;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Recommended: postgraduate studies (Master, PhD);</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Specialized courses;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Minimum 1 year experience in the field;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Knowledge of English (advanced level);</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Knowledge of Microsoft Office;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Has good writing and messaging skills for various audiences;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Has knowledge of medicine and/or clinical pharmacology;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Has experience in completing various information in databases;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Easily correlates specialized information (e.g. how a drug works on the body and its effects);</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Is characterized by a goal-oriented, independent and structured working style;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Very good communication, teamwork skills and flexibility;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Intercultural skills.</span></li> </ul> <p style="margin:0.0in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%">Benefits:</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Unlimited period contract;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Annual performance bonus;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Work from home most of the time (40-60%) – Office work takes place in Sânandrei, Timis County;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Meal tickets;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Health subscription (free or discounted medical services);</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">7 Card subscription;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">A premium for family events, according to the Collective Labor Agreement;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Partial settlement costs for the purchase of eyeglasses;</span></li> <li style="margin-bottom:0.0in;line-height:115%;margin-top:0.0in;margin-right:0.0in;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%">Free coffee and dynamic work atmosphere.</span></li> </ul> <p style="margin:0.0in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%"> </span></strong></p><p><span id="cke_bm_1229S" style="display:none"> </span>B. Braun Shared Services Romania | Adriana Nai | </p>