Description
We are looking for a
Safety Science Leader- mature products (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Responsible for the Safety Science management of a portfolio of mature products
- Ensure that all safety processes are properly supported (pharmacovigilance, signal detection, risk management, benefit/risk)
- Ensure the proper execution of relevant RMP/REMS. Accountable for the proper execution of RMP / REMS tactics when they are delegated to other parties inside or outside the company
- Responsible for the submissions to the NC-DSC and DSC in a timely fashion (including when rapid response is needed) and ensures high quality presentations.
- Responsible for the maintenance of the CDS and for issues unrelated to safety (which are relevant to DSC) approves the changes after review and discussion with Strategic Marketing and Regulatory Affairs
Your qualifications
- Profound experience
- Physician who would be eligible for medical practice in EU or in US (or equivalent such as Switzerland, Australia, Canada, New Zealand, …)
- MD and PhD, post doctorate experience in a specialty such as internal medicine, pediatrics, geriatrics is highly valued
- Oncology experience is an advantage
- In-depth experience at leading teams at a senior level
- Full understanding of the latest EU pharmacovigilance regulations
- Fluent in English
Skills:
- Drug safety manager