Job Objective

• Process and document relevant information regarding drug safety.
• 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).
• 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.
  

Responsibilities

• Prepare and update reports on drug safety (Periodic Safety Update Reports – PSURs, Periodic Benefit-Risk Evaluation Report – PBRERs) periodically.
• Investigate medical literature databases to collect and evaluate relevant articles regarding adverse effects relevant for creating PSURs.
• 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.
• 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.
• Collect, evaluate, and document reports related to drug safety (adverse reactions, pharmaceutical technical defects) in centralized databases.
• 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.
• Support organizational activities in taking measures related to drug safety (such as batch recalls, risk minimization activities).
• Database queries, preparation of statistics, presentations, and other reporting.
• Perform individual tasks for the smooth running of team work, as needed.
  

Your Profile

• Higher studies in pharmaceuticals or medicine; bachelor degree;
• Recommended: postgraduate studies (Master, PhD);
• Specialized courses;
• Minimum 1 year experience in the field;
• Knowledge of English (advanced level);
• Knowledge of Microsoft Office;
• Has good writing and messaging skills for various audiences;
• Has knowledge of medicine and/or clinical pharmacology;
• Has experience in completing various information in databases;
• Easily correlates specialized information (e.g. how a drug works on the body and its effects);
• Is characterized by a goal-oriented, independent and structured working style;
• Very good communication, teamwork skills and flexibility;
• Intercultural skills.
  

Benefits

• Unlimited period contract;
• Annual performance bonus;
• Work from home most of the time (40-60%) – Office work takes place in Sânandrei, Timis County;
• Meal tickets;
• Health subscription (free or discounted medical services);
• 7 Card subscription;
• A premium for family events, according to the Collective Labor Agreement;
• Partial settlement costs for the purchase of eyeglasses;
• Free coffee and dynamic work atmosphere.
  

B. Braun Shared Services Romania | Adriana Nai |
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