Head of Pharmacovigilance

The FDA / EMA and people across the world rely on how safe and how robust clinical trials are conducted. Our client is relying on you to help develop their extensive Immuno-oncology platform. With several key global partnerships supporting their development platform and recent huge cash investments this is promising to become one of the leading immuno-oncology biotechs in Europe.

With numerous assets in the pipeline, safety and risk are key focal points for any innovative biotech. In order to support this cutting-edge technology, my client is seeking a Pharmacovigilance expert to formulate and implement regulatory strategies.

This is a job with extensive responsibility at one of the most exciting biotechs in the world.
If you would like to join their mission, to approach cancer in a novel way and work alongside some of the best medical experts and scientists then continue reading.

Please note this position is largely office-based (with some flexibility for home-based). It does provide relocation and visa support.

Responsibilities:

• Manage all post-marketing safety surveillance activities
• Develop, implement and maintain safety surveillance processes and practices that are compliant
• Set and implement the global safety strategy for all programs ensuring proactive and continuous review and assessment of pre-clinical, clinical, and post-marketing safety data
• Review and interpret the safety portion of clinical trial reports
• Provide guidance to product/program teams and CROs for safety case review and adjudication.

 

As a Head of Pharmacovigilance you will need:

• Extensive previous experience in pharmacovigilance and product safety
• Extensive work designing and/or implementing safety reporting processes, Safety Management Plans
• Ideally some work with oncology.
• Knowledge of global safety reporting regulations (US/ EU/ UK)
• English fluent, German not needed but preferred
• MD or PharmD preferred
• Proven track record of most of the above job responsibilities or transferrable experiences.

Package:

• Competitive salary.
• Flexible working.
• Friendly office space, coffee, tea, social events.
• Housing and child support if needed. Group pension plan.
• Working with some of the newest oncology treatments in Europe.
• Empowering workspace, offering opportunities to share ideas and influence company services development worldwide

Next steps:
If you are interested in this mission, or in general would like to discuss your options in the Pharmacovigilance space then please send your CV in , apply using the website link or contact me. This is what the process will look like (note, this could change depending on you or the client's need);

1. Full call with the executive recruiter responsible.
2. Sharing of the company and confirmation by you to move forward.
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