Senior Clinical Safety & Pharmacovigilance Manager

Senior Clinical Safety & Pharmacovigilance Manager

Bavarian Nordic

Planegg, Germany

We are looking for an analytical thinker who can handle complex data, build up structured processes and communicate information across a global team alike.

Your responsibilities include

  • Managing all Pharmacovigilance aspects of allocated products and studies, in particular including Post Authorization Safety Studies (PASS)
  • Overseeing and maintaining PVA/SDEA management, as well as CRO management in respect to PV
  • Ensuring all assigned projects are set-up in line with the PV standard operating procedures (SOPs) and relevant guidelines
  • Serving as a contact for pharmacovigilance matters internally and externally
  • Contributing to signal management, risk management plans, aggregate reports as well as compliance management while directly reporting to the Head of CSPV and EU QPPV
  • PV audits and inspection management as well as PV training

Skills

  • Quality-oriented personality with a focus on finding easy to implement solutions
  • Effective communication and negotiation skills, being able to work with matrix and local teams as well as with external partners
  • Argus safety database knowledge and data visualization skills
  • Medical writing experience
  • PASS management experience

Your qualifications

  • Medical degree or background preferred
  • At least 5 years of pharmacovigilance experience
  • Strong PV compliance and safety management background, especially in the field of post marketing and PASS
  • In depth knowledge of GVP, FDA guidance documents and in general global PV legislation
  • Audit and inspection experience
  • Excellent command of English and German with strong written and oral skills

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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