Description
We are looking for a
Safety Scientist Leader - Drug Safety (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM
Ort: in the Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Accountable for all aspects of safety related to a product in LCT stage or a group of products in early exploratory phase or mature, including single case assessment, aggregate reporting, integrated signal prediction/detection, integrated risk management process & comparative benefit risk (in collaboration with Clinical and Regulatory) throughout the life cycle
- Leads product-specific safety analyses through leading a cross-functional safety team
- Maintains an integrated safety management plan throughout the life cycle of the product or medicine and is accountable for the safety component of the Early Development Plan/IDCP, study protocols and reports, data evaluation and clinical NDA / BLA preparation as well as various periodic safety reports in order to optimize the benefit/risk profile and communicate it clearly
- Supports the clinical and life cycle teams in bringing the safety expertise in interaction with health authorities, data safety monitoring boards and investigators
- Acquires and contributes knowledge of relevant drug class and/or competitor safety issues
- Contributes to the scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves the submissions from a safety perspective
- Be accountable for the safety components of the study reports , aggregate reports and high level regulatory documents
Ihre Qualifikation
- 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 pharmacovigilance regulations
- Fluent in English
Skills:
- Drug safety manager
Keywords: freelance contractor freelancer contract contr contracting self-employed project Projekt