pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
 

Senior PV Analyst


Your Job

  • Provide consulting, training and/or support on client-facing and internal projects as it relates to the organization’s Argus Hosted service.
  • Analyse business needs presented by clients and/or the internal community – and recommend & implement solutions.
  • Provide project management and/or oversight for both client implementation and pharmasol internal projects.
  • Assist in developing and reviewing pertinent procedure documents (SOPs, WINs, and FAQs) in support of the Pharmacovigilance area, especially as they pertain to the Argus Hosted service.
  • Any other responsibilities as discussed and agreed to with the Business Unit Head and/or COO.
  • Assist in designing, developing, implementing, improving, and maintaining technical solutions and service offerings for the Pharmacovigilance business area – in particular with its Argus rapidLIVE package, covering:
  • System setup and configuration.
  • Validation documentation creation, guidance and execution.
  • Training materials development and conduct.
  • Support during implementation and post go-live.
 

Your Profile

  • Bachelor of Science in the sciences, computer science or comparable education.
  • At least 5 years of Pharmacovigilance-related business experience.
  • At least 5 years of information technology-related experience, preferably in a GxP-relevant, life sciences environment.
  • In-depth knowledge of computerised software validation (GAMP 5) and 21 CFR Part 11.
  • Experience in a consulting or contract research organisation preferred.
  • Strong communication and writing skills (fluent in English; German beneficial).
  • Strong analytical skills and up-to-date technical knowledge.
  • Ability to handle competing priorities and multi-task effectively – whether collaboratively as part of a project team or independently, as dictated by project needs.
  • Highly organized with strong attention to detail.
  • Good comprehension of Pharmacovigilance principles, practices, standards and regulations.
  • Good comprehension of Computerised Software Validation (GAMP 5).


If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
 

Agencies only by prior agreement for the specific job opportunity.