Leading Swiss biotech looking to recruit a Global Safety Lead Physician to be based in Basel.
- Responsible for replying to safety queries from regulatory authorities or healthcare professionals.
- Liaising with experts on an external level, such as safety data review board.
- Offer assistance when required for licensing agreements, such as co-development safety data exchange agreements.
- Oversee end-to-end PV activities, including signal detection, supervising, reviewing, comprehension and suitable management of safety information.
- Assist the management of regulatory health authority inspections when considered essential.
- Medical Doctor (MD)
- 3-5+ years of experience in a CRO/pharma/biotech organization with experience
- Experience working in a medical monitor/ safety physician role with demonstrated knowledge of review of safety cases and drafting of clinical narratives.
- Ideally experience working with clinical development such as trial design, development or study protocol writing - this can be as a lead position or supporting.
- Strong verbal and written communication/presentation skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures.
- High ethical & quality standards demonstrated through actions and communication.
- Demonstrated ability to work independently and seek guidance, when needed.