Head of Pharmacovigilance (m/f/d)

Our client is one of the most traditional German DAX-30 companies in the pharmaceutical industry and generates sales of almost € 20 billion worldwide in the Healthcare division with more than 60.000 employees.

We are looking for three committed and motivated people for the position of a

Head of Pharmacovigilance (m/f/d)

  • Bereich:

    Medical

  • Berufssparte:

    Pharmacovigilance

  • Arbeitsregion:

    Nordrhein-Westfalen

  • Art der Anstellung:

    permanent

  • Kennziffer:

    25971

  • Aktualisierung:

    2020-07-30

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Your tasks

  • Lead and manage the German Pharmacovigilance team and provide medical guidance in PV matters to the company
  • Represent the companies PV system on a local level and keeps the global PV organization aware of relevant changes in the local context. This includes:
    • Being accountable for all PV matter toward the local Health Authorities and the local organization
    • Being responsible to escalate any safety relevant matters and take respective actions to safeguards appropriately use and the benefit risk balance of the companies products on a local level
    • Review of local relevant medical literature according with the PV standard operations and procedures
    • Regular review and analysis of local regulatory context
  • Ensure the legal obligations of the Graduate Plan officer according to German drug law, which includes responsibilities for Product Technical Complaints and Counterfeits
  • Leads the local Safety Management Team and liaise with the relevant expert functions in the local Safety Risk Management Plan development and intervention implementation activities
  • Assist in the maintenance of company's compliance with respect to laws, regulations and guidance associated with the licensure of the companies medicinal products with respect to patient safety
  • Assure the correct implementation and observation of all safety related Standard Operating Procedures, Working Procedures and Operational Instructions of the company referring to local safety activities
  • Assure the collection, review, processing and distribution of adverse event information on a country level regarding the the company products in all therapeutic areas; guides submission of individual case safety reports to the local Health Authorities according to the local regulations
  • Local safety issue and crisis management in collaboration with the Headquarters as well as detection and escalation of local safety observations
  • Education and training within the local organization; documentation of topics addressed during the training and of participants in the training
  • Review the PV components of all domestic study protocols and informed consents and ensures that these parts are compliant with the standards and templates
  • Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. market research, Active-Online-Listening) to ensure Pharmacovigilance principles are applied in the interaction with patients

Your qualifications

  • Physician or Degree in Pharmacy / Natural Sciences with a minimum of 3-5 years-experience in a healthcare organization
  • Strong organizational and process management skills and as well as understanding of business systems
  • Knowledge in Pharmacovigilance relevant regulations and experience in development and authorship of complex PV documents
  • Demonstrated project management capability and preferably in-depth experience in drug development process over different stages, esp. clinical development and clinical operations
  • Highly effective communicator with strong influencing ability and communication skills and experience of leading and contributing to teams across geographies
  • Demonstrated ability to function effectively and successfully in a complex global and multicultural environment
  • Experience of working across and building effective working relationships 
  • Fluency in German and English (written and verbal communication skills)

Your contact person

Tilman Grumbd
Geschäftsführer

Address

Optares Medical GmbH & Co. KG
Tilman Grumbd
Heiligengeist Höfe 8
26121 Oldenburg