Senior PV Specialist


KLIFO is looking for a talented and committed Senior Pharmacovigilance Specialist based in Denmark

KLIFO is expanding our office in Denmark and wants to engage an additional Pharmacovigilance Specialist into a dynamic and experienced team within Pharmacovigilance Solutions. The people we want to engage like to work in an advisory role and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Senior PV Specialist:

The Senior Pharmacovigilance Specialist is responsible for all aspects of pharmacovigilance of own projects including management, planning, PV set-up, execution, monitoring and documentation:

  • Create trial specific Safety Management and SAE flow
  • Handling of the safety database (not necessarily the technical part)
  • Ensure expedited reporting to Competent Authorities and Ethic Committees/Independent Review Board
  • Review and present safety data listings (coding, signals)
  • Write and submit periodic reports
  • Define Reference Safety Information
  • Review documents for safety information
  • Lead or participating in safety oversight committees

The qualifications of the Senior PV Specialist:

  • BSc/MSc in the life sciences field and a minimum of 8-10 years in a similar position in the pharmaceutical industry/BioTech/CRO
  • Experience with pharmacovigilance from both clinical and post-marketing phases
  • In-depth knowledge of international PV guidelines and regulatory requirements
  • Knowledge with device pharmacovigilance is an advantage
  • Experience with safety databases and knowledge of MedDRA and ATC coding
  • Excellent communication skills in English both written and verbal
  • Master Microsoft Office
  • Able to translate client´s needs into solid deliveries.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, newly started biotech, and academia 
  • Build international client relations 
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment 

Location:

KLIFO has offices Denmark, Germany, Sweden and The Netherlands. This position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Randi Rahbæk, Senior Clinical Research Director, at +45 4477 8704

Applications should be sent to: 

moc.ofilk@boj marked Senior PV Specialist. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline:
2 March 2021 (although applications are reviewed on an ongoing basis)

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