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.
- 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.
* 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
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.
3. Introductory call with the hiring manager.
4. Follow up call with the team (1 or 2 calls).
5. Face to face meeting.