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Job content

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.

To strengthen our successful team Ireland, we are looking for a:

Senior Manager Pharmacovigilance (f/m/d)

Your Job

  • Consult clients in all matters related to Pharmacovigilance
  • Plan, set-up, improve and maintain PV systems for clients
  • Take over QPPV role for clients
  • Prepare and review of PV quality management documents (e.g. PSMFs, SOPs, Wis, SDEAs)
  • Review safety reports (e.g. PSURs, RMPs) as Part of the QPPV oversight
  • Contribute to monitoring product safety profiles through signal detection as well as safety issue review
  • Screen product quality complaints regarding safety-relevant issues
  • Answer safety-relevant enquiries from regulatory authorities
  • Perform GVP audits or participate in GVP audits and inspections
  • Instruct and train junior members of the team in all Pharmacovigilance aspects

Your Profile

  • Master’s Degree in medicine, pharmacy or natural science (preferably PHD or MD))
  • Ideally several years of experience in pharmacovigilance and related aspects
  • Detailed knowledge of the applicable legislation (e.g. GVP)
  • Able to operate as Qualified Person for Pharmacovigilance (QPPV) and graduated Plan Officer level
  • Experience with management and steering of projects
  • Strong interpersonal and organizational skills as well as a team-oriented approach
  • High sense of responsibility and self-motivation
  • Highly service orientated
  • Fluency in English, spoken and written
  • Computer literacy and confidence with business applications

We offer

  • Diverse and challenging job
  • Open and appreciative corporate culture
  • Flexible working hours
  • Possibility to work reduced number of hours
  • Possibility to work from home
  • Continuous development opportunities through knowledge and experience as well as training

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.

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Deadline: 29-03-2024

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