Associate (m/f/d) Pharmacovigilance

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:

Associate (m/f/d) Pharmacovigilance

Drug Safety

  • Bereich:

    Medical

  • Berufssparte:

    Pharmacovigilance

  • Arbeitsregion:

    Greater Munich Area

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    26513

  • Aktualisierung:

    27.05.2021

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Your tasks

  • Support the management of third-party Pharmacovigilance vendor processes and internal processes for safety activities within an ongoing phase II to phase III clinical program.
  • Receiving, tracking, and filing of SAEs and expedited event reports and surveillance of timely processing by third-party vendor
  • Provide sponsor oversight of SAE processing by an outsourced vendor including the monitoring of reporting compliance.
  • Coordinate case review with InflaRx Medical Affairs personnel and ensure implementation of recommendations.
  • Coordinate on time data preparation with third-party vendor for periodic safety assessment (DSUR, IB, DSMB)
  • Contribute to vendor surveillance with regards to invoice verification and cost control.
  • 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.

Your qualifications

  • Bachelor’s degree in Life Science/Pharmacy/Medical Sciences, or other equivalent experience/education.
  • A minimum of 6 months of relevant experience in a pharmaceutical/ biopharmaceutical organization with safety reporting (expedited/periodic) in clinical development.
  • First experience with safety reporting and general regulatory environment in a clinical development environment.
  • 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
  • Highly motivated, self-driven, dependable, and solution oriented.
  • Effective communication skills.
  • Fluent in written and verbal business English. Fluency in German desirable.
  • Should 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