Drug Safety Operations Manager

Vor 6 Tagen


Geneve, Schweiz OM Pharma Ltd. Vollzeit

Location: Meyrin, Geneva, CH- Division:
- Division: Drug Safety- Job Type: Permanent roleFollowing an internal transfer, we are recruiting a **Drug Safety Operations Manager **based at our headquarters in Geneva. Reporting to the Drug Safety Head and supported by a Drug Safety Operations Specialist, you are responsible for the whole process of case management, data management and safety agreements management according to ICH/FDA/EMA and Swissmedic guidelines compliance.

Your main responsibilities are as follows:

- Act as key contact point for case management, data management and safety agreements management
- Manage, coach and develop 1 direct report, the Drug Safety Operations Specialist
- Ensure, in close collaboration with any service provider, that all subcontracted tasks related to the safety database, data management or case management are properly conducted in due time
- Participate in case processing steps in the safety database (case quality control)
- Maintain and optimize the OM Pharma global safety database (Veeva Vault Safety configurations and releases)
- Set-up, review and improve all procedural documents, instructions, working documents and forms/templates related to case management, data management and safety agreements management
- Participate in safety reconciliation with partners and affiliates
- Development of Safety Data Exchange Agreements (SDEA) with partners and affiliates/vendors
- Generate line listing and summary tabulations for Aggregate Safety Reports or any other requested safety reports
- Perform data extraction for signal detection and other internal/external purpose (data requests, answers to health authorities, dossier updates.)
- Participate to audits and inspections as Subject Matter Expert (SME) for case management, data management and SDEA management
- Collaborate with the Drug Safety Head, the EU QPPV and the Drug Safety Medical Managers for the implementation and improvement of Pharmacovigilance system and processes

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

- University Degree (MSc / PhD) in Life Sciences, Pharmaceutical Sciences or Medical
- At least 5 years of experience in Drug Safety, including 3 years in case management
- Excellent knowledge of international regulations (ICH, Volume 9A/10, EMA GvP, FDA regulations and Swiss regulations)
- Comfortable with the use of safety databases (ideally, Veeva Vault Safety)
- 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. Thanks to your natural leadership and good communication skills, you feel comfortable in a position where you give guidance and take initiatives to make things move forward. You are also solution-oriented and always look for continuous improvement.

**About Us**:
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.



  • Geneve, Schweiz OM Pharma Ltd. Vollzeit

    Location: Meyrin, Geneva, CH- Division: - Division: Drug Safety- Job Type: Permanent roleWe 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...


  • Geneve, Schweiz International Air Transport Association (IATA) Vollzeit

    Employment Type: Permanent Contract Duration: About the team you are joining You will be joining the IATA Certification team based in Geneva and reporting to the Principal, IATA Certification. The Product Manager will be responsible for the management of the operation, safety and security certifications portfolio, including CEIV Lithium Batteries, Smart...


  • Geneve, Schweiz FEDERATION INTERNATIONALE AUTOMOBILE Vollzeit

    12-04-2024 ROAD SPORT SAFETY MANAGER **ROAD SPORT SAFETY MANAGER (Geneva - Switzerland)**: Under the responsibility of the Head of Operational Safety, the Road Sport Safety Manager applies his/her expertise and knowledge to improve safety on Road Sport disciplines worldwide, ranging from national to World Championship level. **MISSIONS AND...


  • Geneve, Schweiz Medicines for Malaria Venture (MMV) Vollzeit

    Medicines for Malaria Venture (MMV) is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs. Over the past two decades, MMV has worked...


  • Geneve, Schweiz Microsoft Vollzeit

    In alignment with our Microsoft values, we are committed to cultivating an inclusive work environment for all employees to positively impact our culture every day and we need you as a **Datacenter Security Operations Manager.** As a Datacenter Security Operations Manager in CO+I Physical Security, you will be part of a global team dedicated to delivering...


  • Geneve, Schweiz THE BRAINS Vollzeit

    We are partnering with a prominent organization that is recognized for its commitment to innovation, safety, and continuous learning. With a multicultural and dedicated workforce, they emphasize core values that focus on collaboration, progressive thinking, taking ownership, and consistently delivering high value to their clientele. **Team Manager...

  • Head of Safety

    vor 2 Monaten


    Geneve, Schweiz Geneva Call Vollzeit

    **Mission**: - Geneva Call is a neutral and impartial non-governmental organization dedicated to promoting respect by Armed Groups and de Facto Authorities (AGDA) for international humanitarian norms in armed conflict and other situations of violence, in particular those related to the protection of civilians. Geneva Call focuses its efforts on banning the...

  • Fbo Manager

    vor 2 Wochen


    Geneve, Schweiz C&J Vollzeit

    FBO Manager **Job Description**: We're in search of a skilled and dedicated FBO Manager to oversee our aviation facility. As the FBO Manager, you'll be responsible for ensuring smooth operations, exceptional service, and adherence to safety standards within the Fixed-Base Operator (FBO). **Responsibilities**: - Oversee all aspects of FBO operations,...


  • Geneve, Schweiz Orange Vollzeit

    Manage all aspects of Sales operations activities, including sales performance and associated KPI, sales compensation, planning cycles together with Finance, reporting and analysis, and special projects. In details: - Support Sales Manager / Country Manager to drive efficiently their organization with, pipeline and order evolution and changes, sales...


  • Geneve, Schweiz MSC Cruises Vollzeit

    The Ground & Terminal Operations Product Manager will be responsible for supervising the performances of the Ground and Terminal operations team, ensuring that all activities are carried out safely, efficiently, and incompliance with all relevant regulations and standards. The role involves coordinating with the Local head of Ground & Terminal operations and...


  • Geneve, Schweiz FEDERATION INTERNATIONALE AUTOMOBILE Vollzeit

    **MISSIONS AND RESPONSABILITIES**: Proposing and supervising the operating budget of the Operational Safety Group. Driving revenues through circuit licensing business and propose new business opportunities. Supervising and continuously improve the circuit homologation process. Supervising the development of simulation tools that allow to conduct circuit...

  • System Safety Expert

    Vor 6 Tagen


    Geneve, Schweiz skyguide Vollzeit

    Skyguide provides air navigation services in Switzerland and parts of neighbouring countries. With around 1500 employees from more than 30 nations, we are pursuing an ambitious innovation strategy that is based on a strong safety and learning culture. We are guided by four values: “We team up to succeed”, “We drive innovation”, “We own what we...


  • Geneve, Schweiz World Economic Forum LLC Vollzeit

    The World Economic Forum, committed to improving the state of the world, is the international organization for public-private cooperation. The Forum engages the foremost political, business and other leaders of society to shape global, regional and industry agendas. Why we are recruiting This position is part of the Centre for Industry Transformation...


  • Geneve, Schweiz skyguide Vollzeit

    With 1500 employees from more than 30 countries and cultures working at 14 sites, Skyguide provides air traffic control services for Switzerland and parts of neighbouring countries. In 2021, Skyguide safely and efficiently guided around 0.7 million (in previous years around 1.3 million) civil and military aircraft through the busiest airspace in...

  • Cmc Manager

    vor 3 Wochen


    Geneve, Schweiz Stalicla SA Vollzeit

    STALICLA is an international and fast-growing biopharmaceutical company on a mission to build a new therapeutic space for patients with disorders of the developing brain. As the company is rapidly scaling, STALICLA is looking to recruit a seasoned and agile PreClinical Safety Expert to support the next stages of the company’s development. **CMC...

  • Cmc Project Manager

    vor 3 Wochen


    Geneve, Schweiz Alentis Therapeutics AG Vollzeit

    **Job Profile**: The CMC operations project manager is responsible for coordinating, planning, managing and administering the outsourced CMC activities for Alentis monoclonal antibody products. The position includes and the preparation of CMC regulatory dossiers. His function will report to the CMC Program Lead. **Responsibilities**: **Technical**: -...


  • Geneve, Schweiz International Air Transport Association (IATA) Vollzeit

    Employment Type: Permanent Contract Duration: Until end 2025 At IATA, we speak for the airlines of the world, serving and supporting over 300 of them across all continents. We are passionate and knowledgeable about the aviation industry, and we strive to make it safer, smarter, more sustainable and more inclusive. We celebrate diversity and inclusion in our...


  • Geneve, Schweiz International Air Transport Association (IATA) Vollzeit

    Employment Type: Permanent Contract Duration: Until end 2025 At IATA, we speak for the airlines of the world, serving and supporting over 300 of them across all continents. We are passionate and knowledgeable about the aviation industry, and we strive to make it safer, smarter, more sustainable and more inclusive. We celebrate diversity and inclusion in our...


  • Geneve, Schweiz Bottomline Vollzeit

    **Who Are We?** Bottomline is on a mission to be the world's leading business payments company, aligning our team to the common purpose of transforming the way businesses pay and get paid. It is a journey that goes around the world serving financial institutions and companies in more than 90 countries. Our offices across EMEA are conveniently positioned to...


  • Geneve, Schweiz FEDERATION INTERNATIONALE AUTOMOBILE Vollzeit

    **MISSIONS AND RESPONSABILITIES**: - Proposing and supervising the operating budget of the Safety Equipment & Homologation Group. - Driving revenues through FIA label ("holograms") on homologated equipments and propose new business opportunities. - Developing and implementing cost-effective safety standards and safety regulations by liaising with safety...