Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. Along with its unique business model, the success of Debiopharm is also based on its high level of expertise and talented people in various areas such as pre-clinical and clinical development, drug manufacturing, drug delivery, formulation, and regulatory affairs.
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 and Pharmacovigilance Officer
Reporting to the Head of Clinical Safety & Pharmacovigilance, you will manage safety activities for a portfolio of Debiopharm compounds (both in development and marketed) 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 and Pharmacovigilance.
- Ensures reconciliation between the clinical and safety database.
- Coordinates Development Safety Update Reports (DSURs), Safety Management Plans, and reviews Periodic Safety Update Reports (PSURs), Risk-Management Plans (RMPs).
- Ensures Signal detection activities for products in development as a member of the Safety Assessment Committee.
- Maintains the Pharmacovigilance System Master File.
- Collaborates with license partners and ensures maintenance of Pharmacovigilance Agreements and workflow documents for both marketed products and compounds in development.
- Creates and maintains local SOPs & Working Instructions.
- Participates in audits and inspections.
- Manages CROs for relevant sub-contracted activities.
- Degree in Biology, Pharmacist or Medical Director.
- More than 5 years of experience in clinical safety and/or pharmacovigilance with ideally good knowledge of the EU and US regulations.
- Successful track record in managing external partners.
- XEVMPD and Eudravigilance training certificates would be an asset.
- Solid writing and editorial skills, as well as familiarity with medical terminology.
- Fluent in speaking and writing both in English and French.
- Experience in Oncology drug development preferred.
- Team player, used to work in a matrix organization.
- Good communication skills and ability to interact with a wide range of people.
- High degree of initiative and ability to work independently.
- Detail oriented.
Debiopharm can offer you
- 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.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please follow this link to send your application
For more information : www.debiopharm.com