Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). It focuses on products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and potentially life-threatening conditions.
In order to strengthen our Development Department we are looking for an experienced:
Drug Safety Physician (M/F)
- Provide medical review and assessment (seriousness, expectedness, causality, coding, required follow-up) of spontaneous case reports and adverse event reports from clinical trials, observational studies
- Identify individual case safety reports (ICSRs) or other important safety data from the literature
- Develop and maintain a safety profile surveillance strategy for the assigned compounds depending on development/marketing stage
- Ongoing pro-active signal detection for marketed products and evaluation, including presentation to the Drug Safety Committee, as needed
- Main author for aggregate safety reports such as periodic safety reports and annual safety reports
- When applicable, drive preparation of Risk Management Plan as required by health authorities in different regions
- Respond to queries relevant to safety from health authorities, affiliates, distribution/development partners and other internal or external sources
- Responsible for the safety sections of Investigator's Brochure, Core Safety Information, summary of product characteristics, study reports, regulatory documents/briefing books (original generation and revisions)
- MD degree, additional Pharmacovigilance training
- Minimum of 2 years of experience within the pharmaceutical industry
within drug safety
- Well organized and structured, able to manage the work in an multi-functional matrix
- Quality focused and team oriented, with strong analytical and operational skills
- Excellent communication and interpersonal skills
- Fluent in written and spoken English, German would be advantageous
- Strong IT-user skills in MS-Office programs
We offer an interesting and varied work environment in a dynamic future-oriented enterprise with a highly motivated team, a competitive salary and benefits.
We look forward to receiving your online application including your complete documents. For additional information please contact Ms. Nadine Pfrüner.