pharmalex_job_career

We are growing, grow with us!

Do you want to work in 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 global pharmaceutical industry and is specialized in all aspects of drugs and medical devices from development to approval as well as product maintenance. The success of our company grows with the excellent expertise and the high motivation of our employees. If for you, your profession is not only a job but a mission too and you enjoy working with people and in teams, then you are highly welcome to  join us. As of now we would like to strengthen our  successful team (in Friedrichsdorf, Germany or home-based) and 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 and GPO (Graduated Plan Officer (Stufenplanbeauftragte/r))  roles 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
  • Participate in GVP audits  and inspections 
  • Instruct and train junior members of the team in all Pharmacovigilance aspects

We offer you

  • Diverse and challenging tasks paired with methodological knowhow
  • Cooperative partnership in truly interdisciplinary teams
  • Chance to take ownership and responsibility
  • Flexible working hours 
  • Continuous development opportunities through knowledge exchange 

Your Profile

  • Master’s Degree in medicine, pharmacy or natural science 
  • Ideally several years of experience in Pharmacovigilance and related aspects
  • Detailed knowledge of the applicable legislation (e.g. GVP, AMG)
  • 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


If you are interested to take over this most challenging job opportunity in our future-oriented company and want to develop yourself as well as our company, we look forward to receiving your application documents stating your earliest possible starting date on-line.

Your contact person:

Ms. Lena Schlager
www.pharmalex.com
PharmaLex GmbH
Harrlachweg 6
68163 Mannheim, Germany
Tel.: +49 621 18 15 38 224