Drug Safety Medical Manager
vor 1 Monat
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.Drug Safety Medical Manager (h/f) - Geneva
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
-
Regional Health, Safety and Environment Manager
Vor 2 Tagen
Meyrin, Schweiz Richemont VollzeitCritères de l'offre **L'entreprise**: Richemont Richemont Description du poste The Regional Health, Safety and Environment Manager reports to the Richemont Europe Physical Security, Health & Safety and Building & Office Services Director. The position is based in Meyrin (Geneva), within our 'Campus Genevois de Haute Horlogerie'. Your main missions...
-
Manager Industrialization, Pilot Plant Geneva
Vor 3 Tagen
Meyrin, Schweiz Firmenich VollzeitAt Firmenich people are at the heart of the company, we are committed to equal employment opportunities and value diversity in the workplace. Manager Industrialization, Pilot Plant Geneva **Location**: Satigny, Geneva, Switzerland **Key Responsibilities**: Contribute to the development of new products and processes by leading the regional pilot plant in...
-
Project Manager Formula Life Cycle Mgt
vor 1 Woche
Meyrin, Genf, Schweiz DSM-Firmenich AG VollzeitProject Manager Formula Life Cycle ManagementGeneva, SwitzerlandHybrid Support stakeholders to define project goals, scope, timing, and resource allocation. Develop and implement communication strategies and implement a reporting process to permanently report statuses and achievements At dsm-firmenich, being a force for good is not optional. Diversity,...
-
International Security Manager
Vor 6 Tagen
Meyrin, Schweiz Cartier VollzeitCode de référence: 89233**International Security Manager**: - Meyrin, GE, CH- PermanentL’histoire de Cartier repose sur l'audace et la passion. Nous avons adopté un esprit pionnier et audacieux qui continue d’inspirer nos équipes, tous métiers confondus, de nos boutiques à nos ateliers et nos sièges sociaux depuis plus de 170 ans. Nous comptons...
-
Office Manager Et Assistant Comptable
Vor 5 Tagen
Meyrin, Schweiz BOCCARD VollzeitDescription de l'entreprise Depuis 1918, Boccard s'est imposé, en France et dans le monde, comme un acteur majeur dans la conception et la réalisation d'installations industrielles toujours plus performantes et innovantes. Boccard se positionne comme un Ensemblier Industriel de référence intégrant les expertises d’Engineering, de Manufacturing, de...
-
Project Manager Formula Life Cycle Management
Vor 2 Tagen
Meyrin, Schweiz DSM VollzeitProject Manager Formula Life Cycle Management Geneva, Switzerland Hybrid Support stakeholders to define project goals, scope, timing, and resource allocation. Develop and implement communication strategies and implement a reporting process to permanently report statuses and achievements! At dsm-firmenich, being a force for good is not optional....
-
Project Manager Formula Life Cycle Mgt
vor 2 Wochen
Meyrin-Satigny, Schweiz DSM-Firmenich AG VollzeitProject Manager Formula Life Cycle ManagementGeneva, SwitzerlandHybrid Support stakeholders to define project goals, scope, timing, and resource allocation. Develop and implement communication strategies and implement a reporting process to permanently report statuses and achievements! At dsm-firmenich, being a force for good is not optional. Diversity,...
-
Business Process Owner
Vor 6 Tagen
Meyrin, Schweiz Georg Fischer Vollzeit**Your tasks****: - Optimize the sales journey from quote to order management. - Define and develop sales reporting capabilities, together with input from sales and marketing team. - Play an active role to represent the business on the transformation journey, especially in the development of the future quoting tool (CPQ). - Quote expert in charge to...
-
Project Coordinator
Vor 6 Tagen
Meyrin, Schweiz Georg Fischer Vollzeit**Your tasks****: - Support business transformation project management with their activities in accordance with the TranS/4mation framework, standards and processes - Ensure project and workstream level planning is in line with the planning principles and standards - Coordinate project administration requirements, including project working locations, hotel,...