Pharmacovigilance Project Manager

hace 4 semanas


Zaragoza, Zaragoza, España Pharmalex Gmbh A tiempo completo

Company Overview

We are a dynamic and growing company with daily new challenges and opportunities. Pharmalex Gmbh is one of the leading service companies for the Pharmaceutical Industry globally, specialized in all aspects of drugs and medical devices approval, market development, and effective product maintenance.

Job Description

As our Senior Pharmacovigilance Specialist, you will be responsible for professional leadership and provision of pharmaceutical expertise to clients in the field of pharmacovigilance. Your tasks will include management of new pharmacovigilance projects under the supervision of a Manager. You will also provide operational support as a Local Literature Surveillance expert, searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and relevant information. Additionally, you will review and approve changes in literature searches or new strategies and QCs, monitor timelines and KPIs following internal SOPs, and manage ICSR (Individual Case Safety Report) information, including MedDRA and ATC coding of Adverse Drug Reactions and Adverse Events, initial processing of incoming information, translation of incoming information into English language including QC, data entry into PV database (SafetyEasy or client DB) and/or case tracking system e.g. Excel, and preparation of standard reporting forms (i.e.: CIOMS I, Medwatch forms and XML files).

Required Skills and Qualifications

  • Bachelor's degree in Life Science or demonstrable experience in Pharmacovigilance.
  • Very good command of English.
  • Autonomous, concentrated, and high-quality work.
  • Ability to work in a team.
  • Sense of responsibility.
  • Knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance.
  • Familiarity with industry principles of pharmacovigilance.
  • Knowledge of pertinent medical or pharmaceutical concepts.
  • Detailed knowledge regarding project-related SOPs (internal and client-specific), global and local PharmaLex SOPs, and pharmacovigilance-related SOPs.
  • Self-confidence and assertiveness.
  • Strategic, analytical, and structured thinking.

Benefits

We offer diverse tasks and challenging projects, very open, pleasant, and collegial cooperation, international company with various development and career opportunities, continuous development opportunities through exchange of knowledge and experience as well as further training courses, compatibility of work, family, and private life, flexible working hours, and possibility to work partly from home.

Salary: € 60,000 - 80,000 per year, depending on your qualifications and experience. If you are interested in joining our Pharmalex Gmbh team, we are looking forward to receiving your application documents stating your earliest possible starting date, any visa requirements, and salary expectations online. Agencies only by prior agreement for the specific job opportunity.



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