Senior Global Clinical Safety Officer

Clinical Safety & PharmacovigilanceLausanne, Vaud, SwitzerlandFull time

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Description

Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For our Clinical Research & Development Department, we are looking for an experienced specialist to be based at our headquarters in Lausanne as

Senior Global Clinical Safety Officer (100%)

Reporting to the Head of Clinical Safety & Pharmacovigilance, you will manage safety activities for a portfolio of Debiopharm compounds in development in compliance with relevant regulations and Standard Operating Procedures (SOPs).

Main responsibilities:

• 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


• Ensures the appropriate filing of clinical safety documents in the eTMF


• Collaborates with license partners and ensures maintenance of Pharmacovigilance Agreements and workflow documents forboth marketed products used in clinical trials with our products in development;


• Creates and maintains local SOPs & Working Instructions


• Participates in audits and inspections


• Manages CROs for relevant sub-contracted activities


• Is the back-up person for other clinical safety officers

Requirements

• Degree in Biology, Pharmacist


• More than 5 years of experience in clinical safety with good knowledge of EU and US regulations

• 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


• Good communication skills and ability to interact with a wide range of people


• Ability to solve problems and to anticipate them


• Flexible and willing to support and work with employees at all levels in the organization and across all functions;


• Team player able to develop credibility with team members


• Technology-savvy in all Microsoft Office 365 applications


• Demonstrate excellent written and verbal communication skills in English and French

Benefits

• 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

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