PV Manager
Clinical Development and Operations is the most important part of a growing biotech. It is the difference between helping millions of people on time or making them wait years. 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 hottest ImmunoOncology biotechs in Europe. Their key molecule is used in precision oncology treatments, priming immune responses to specific RNA nucleopeptides in the individual. This is having dramatic changes in people’s lives – where once only extensive chemo (or no treatment) was available, they are changing this.Cancer is responsible for millions of deaths each year with some being very difficult to treat – this biotech is using innovative approaches to try and change that. 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.
As a PV Manager you will be responsible for
;- Setting and implementing the strategy for global pharmacovigilance and safety operations for a portfolio of products;
- Supportung the implementation of of post-marketing Pharmacovigilance processes; -Contributing to the Risk Management Plan of the product;
- Guiding product/program teams and CROs for safety case review and adjudication;
- Representing the company on teams for assigned products/programs; -Collaborating with partners to ensure coordinated safety reporting activities;
- Participating in the review and interpretation of clinical trial results ( to understand and interpretate the safety of the product) .
As a PV Manager you will need:
- Scientific Degree background;
- Experience designing safety reporting processes, systems, and tools to support both case-level review and trend analyses ;
- At least 5 years of pharmacovigilance or product safety experience;
- Previous work within oncology– either in Solid or Haematological;
- Experience with safety reporting and analysis of biologic treatments/ATMP is preferred;
- English fluent, German not needed but preferred;
- Experience developing and implementing Safety Management Plans is required; -Proven track record of most of the above job responsibilities or transferrable experiences.
Package:
- Competitive salary.
- Flexible working ( 50% home based)
- Friendly office space, coffee, tea, social events.
- Extensive Oncology and Haematology portfolio to work with including Immunotherapy, CART and other scientific approaches.
- Housing and child support if needed. Group pension plan.
- Working with some of the newest oncology treatments in Europe.
- Being lead in an open work culture and under the leadership of 3 highly respected oncologists and industry veterans.
- Empowering workspace, offering opportunities to share ideas and influence company services development worldwideNext steps:If you are interested in this mission, or in general would like to discuss your options in the Clinical Development and Medical space then please send your CV in at or call me at +44 2038790716.This is what the process will look like (note, this could change depending on you or the client’s need);
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.
6. Offer.This will be confidential and your CV will not be shared to anyone without your permission. Please apply today or reach out confidentially.
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