Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.
For our Clinical Research & Development Department, we are looking for an experienced specialist to be based at our headquarters in Lausanne as
Senior Clinical Safety Officer - Temporary 6 Months
Reporting to the Head of Clinical Safety & Pharmacovigilance, you will be in charge of the implementation of CAPAs and manage also safety activities for a portfolio of Debiopharm compounds in development in compliance with relevant regulations and Standard Operating Procedures (SOPs) .
- Manages case processing for clinical trials and electronic reporting to Health Authorities
- Manages the interactions with internal departments as well as vendors, sponsors, commercial partners and CROs in the area of Clinical Safety
- Ensures reconciliation between the clinical and safety database
- Coordinates Development Safety Update Reports (DSURs),
- Writes Safety Management Plans,
- Ensures Signal detection activities for products in development as a member of the Safety Assessment Committee
- Ensures the appropriate filing of clinical safety documents in the eTMF;
- Implements CAPA changes to update the system and processes
- Creates and maintains local SOPs & Working Instructions
- Collaborates with license partners and ensures maintenance of Pharmacovigilance Agreements and workflow documents for products used in clinical trials with our products in development;
- Participates in audits and inspections
- Manages CROs for relevant sub-contracted activities
- Is the back-up person for other clinical safety officers.
- Degree in Biology, Pharmacist
- More than 7 years of experience in clinical safety with good knowledge of EU and US regulations
- Experience in audit and/or inspection and implementation of CAPA changes
- Successful track record in managing external partners
- XEVMPD and Eudravigilance training certificates would be an asset
- Strong experience with a Safety Database
- Solid writing and editorial skills, as well as familiarity with medical terminology
- Experience in Oncology drug development preferred
- Team player, used to work in a matrix organization
- Demonstrate excellent written and verbal communication skills in English and French
- An international and highly dynamic environment, with a long-term vision.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests that external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.