Drug Safety Medical Manager

OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases. It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections. The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances. For more information, visit the website: ompharma.com. We are recruiting a Drug Safety Medical Manager based at our headquarters in Geneva. Reporting to the Drug Safety Head, and working in close collaboration with the Clinical, Medical and Regulatory Affairs departments, your mission is to ensure Swiss and international compliance for assigned OM Pharma Suisse SA and OM Pharma SA products. Your main responsibilities are as follows:

• Ensure ICH/FDA/EMA and Swissmedic Guidelines compliance
• Act as Drug Safety/Pharmacovigilance representative in the Clinical-Medical-Regulatory-Safety Team (CMRST) and as Subject Matter Expert in the Product Benefit Risk Committee (PBRC)
• Manage the whole process of signal detection and literature review
• Ensure, in close collaboration with any service provider, that all subcontracted tasks related to medical writing are properly conducted in due time
• Perform medical evaluation of adverse event reports
• Collaborate with Clinical research department and Biometrics in clinical safety data sets
• Collaborate with Regulatory Affairs for the planning of Aggregate Safety Reports
• Ensuring regular reviews and updates of all procedural documents related to aggregate safety report, literature review and signal detection processes
• Participate to audits/inspection and implement CAPAs on an effective and timely manner
• Collaborate with the Drug Safety Head, the EU QPPV and the Drug Safety Operations Manager for the implementation and improvement of Pharmacovigilance processes
• Act as deputy of Drug Safety Head and back-up for Case Management

To carry out this mission, we are looking for a person with the following profile:

• Medical Degree or PhD with experience in International Drug Safety, or equivalent educational background
• Minimum 5 years of experience within the pharma industry in the fields of data analysis, signal detection, benefit/risk evaluation, aggregate safety reports and literature review
• Excellent knowledge of EU, Swiss and international regulations (ICH, EMA GvP, Swissmedic and FDA regulations)
• Fluency in English with good oral skills in French

Following OM entrepreneurial spirit, you enjoy working in a fast-paced environment and you describe yourself as a strategic thinker with a hands-on attitude. You apply a client-centric mindset, you demonstrate a strong team spirit and you bring good communication skills, which allows you to easily establish collaborative professional relationships with different stakeholders. Finally, you are also solution-oriented and you feel comfortable in a position where you make decisions and take initiatives to move things forward. Are you interested in this opportunity? Apply as soon as possible and join OM Pharma!