Pharmacovigilance Manager (m/f/d)

Drug Safety

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort

 

To support their expanding Drug Safety Team we are looking for a:

Pharmacovigilance Manager (m/f/d)

Drug Safety

  • Bereich:

    Medical

  • Berufssparte:

    Pharmacovigilance

  • Arbeitsregion:

    Munich

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    26512

  • Aktualisierung:

    18.03.2021

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Your tasks

  • Independently manage the third-party Pharmacovigilance vendor outsourced for Clinical Trial activities within an ongoing phase II to phase III clinical program.
  • Represent the Drug Safety Department in program and study teams and in external study team meetings.
  • Contribute to /Manage the set-up of new safety projects, including development of study-specific Safety Management Plans and contractual agreements with third-party vendor.
  • Provide sponsor oversight of SAE processing by an outsourced vendor including the monitoring of reporting compliance (by KPIs) and ensuring a high standard of case narrative writing by quality review.
  • Collaborate with Medical Affairs personnel to monitor and maintain high quality of SAE reporting
  • Ensure vendor surveillance with regards to cost control, on time completion of outsourced activities and on-budget delivery of pharmacovigilance services.
  • Contribute to evaluation, analysis and presentation of safety data in respective documents (DSUR, IB, CSR) and in collaboration with independent expert boards (DSMB).
  • Proactively drive cross-functional activities and work with external partners to maintain high quality safety processing.
  • Ensure compliance with SOPs, GCP, and relevant regulatory environment of activities and documentation.
  • Maintain knowledge of adverse event reporting processes and safety systems and contribute to the development, implementation, improvement, and standardization of new processes and methods.
  • Participate in and support internal/external inspections and audits.

Your qualifications

  • Bachelor’s or Masters’ degree in Life Science/Pharmacy/Medical Sciences, or other equivalent experience/education.
  • More than 3 years of relevant experience in a pharmaceutical/ biopharmaceutical organization with safety reporting (expedited/periodic) in clinical development.
  • Good understanding and working knowledge of safety reporting and general regulatory environment in a clinical development environment.
  • Knowledge of clinical operations and biopharmaceutical drug development activities and processes would be advantageous.
  • Experience with immunologically active pharmaceutical products would be advantageous.
  • Ability to work harmoniously within international cross-functional teams, engage in open, constructive and continuous dialogue with internal staff and external partners.
  • Target orientation and flexibility to adapt to changing situations in a fast-paced environment
  • Ability to plan, organize and manage multiple projects and priorities simultaneously
  • Highly motivated, self-driven, dependable, and solution oriented.
  • Effective communication and presentation skills.
  • Fluent in written and verbal business English. Fluency in German desirable.
  • Must be familiar with MS Word, Excel and PowerPoint.

 

Ihr Ansprechpartner

Tilman Grumbd
Geschäftsführer

Anschrift

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