Drug Safety Medical Manager

vor 5 Stunden


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 compliance for 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
- Participate to audits/inspection and implement CAPAs accordingly, 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 Drug Safety 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 in data analysis, signal detection, benefit/risk evaluation, aggregate safety reports and/or 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

**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 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...

  • Drug Safety Head

    vor 1 Tag


    Geneve, Schweiz OM Pharma Ltd. Vollzeit

    Location: Meyrin, Geneva, CH- Division: - Division: Drug Safety- Job Type: Permanent roleWe are recruiting a **Drug Safety Head** based at our headquarters in Geneva. At this position, your mission is to lead our Drug Safety department and ensure Swiss and international compliance for OM Pharma Suisse SA and OM Pharma SA products. You have the unique...


  • Geneve, Schweiz Axepta SA Vollzeit

    We are looking for a Medical Information Manager, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices, located in Geneva. **Responsibilities**: You will be responsible for the management of the company's medical information and will also support the Medical Affairs Department for the Post-Marketing Surveillance...


  • Geneve, Schweiz Labcorp Vollzeit

    If you are looking for a company where you can gain exposure to a wide variety of science and explore a multitude of career paths across the drug development spectrum, consider working at Labcorp Drug Development as a **Laboratory Supervisor in our Safety Testing department based in Geneva**. In this role, you will directly oversee and be responsible for...

  • Medical Affairs Lead

    vor 2 Wochen


    Geneve, Schweiz Axepta SA Vollzeit

    As part of the global growth of our client, a biotech company based in Geneva, we are recruiting a Medical Affairs Lead whose main mission will be to identify outstanding medical needs and define the global medical business strategy in line with the brand's strategic plan. **Responsibilities**: - Lead a team of 2 global medical affairs managers - Work on...


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

    Employment Type: Permanent Contract Duration: About the team you are joining The Manager, Safety Management Systems reports to the Senior Manager, Safety Risk within the Safety Risk & Quality Assurance team, an exciting and dynamic team that plays a key role in the delivery of IATA’s wider safety strategy. The team works closely with other technical areas...


  • Geneve, Schweiz JTI - Japan Tobacco International Vollzeit

    We’re JTI, Japan Tobacco International and **we believe in freedom**. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our **consumers to choose from**. It’s how we’ve grown to be present in 130 countries. But our business isn’t just...

  • Medical Affairs Manager

    vor 7 Monaten


    Geneve, Schweiz OM Pharma Ltd. Vollzeit

    Location: Meyrin, Geneva, CH- Division: - Division: Medical Affairs- Job Type: Permanent roleWe are currently looking for a **Medical Affairs Manager** at our global headquarters in Geneva. Reporting to the Medical Affairs Lead, and working in close collaboration with the Brand Team, your mission is to contribute to the definition and to execute the global...

  • Drug Discovery Leader

    Vor 6 Tagen


    Geneve, Schweiz Drugs for Neglected Diseases Initiative Vollzeit

    The Drugs for Neglected Diseases _initiative_ (DND_i_) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases that affect millions of the world’s poorest people. Together with more than 200 public research and industry allies worldwide, we use the power of...


  • Geneve, Schweiz Interiman Vollzeit

    **INTRODUCTION**: For one of our clients, an international NGO based here in Geneva, we are looking for a: **Medical Application Project Manager** Temporary mission - 100% **ASSIGNMENT DESCRIPTION**: **Duties and responsibilities**: - The Medical Application Project Manager will work in close collaboration with the ICT Project Manager to follow up on...


  • 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...


  • Geneve, Schweiz Labcorp Vollzeit

    We are recruiting for our global Medical Team and are keen to speak with physicians with a specialism in **Neuroscience**. The group plays a pivotal role in the drug development process through strategic consulting, medical monitoring and clinical trial development. The leader will bring a track record of success in previous roles and be able to demonstrate...


  • 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...

  • Intern, Safety Risk

    Vor 2 Tagen


    Geneve, Schweiz International Air Transport Association (IATA) Vollzeit

    Employment Type: Internship Contract Duration: 6 months About the team you are joining Safety is aviation’s highest priority. By joining IATA Safety Risk and Quality Assurance Team, you will gain an understanding of the aviation industry’s unique challenges. You will have the opportunity to work with experienced aviation professionals across multiple...


  • 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...


  • Geneve, Schweiz ICRC Vollzeit

    **Requisition ID**: 18869 **Region**: Europe (HQ) **Contract type**: Open-ended contract What we do The International Committee of the Red Cross (ICRC) works worldwide to provide humanitarian assistance to people affected by conflict and armed violence. We take action in response to emergencies and at the same time promote respect for international...

  • Occupational Nurse

    vor 1 Woche


    Geneve, Schweiz Johnson Controls Vollzeit

    **Job Details** This position is responsible to provide primary and emergency nursing care for all Norman plant employees as well as planning, developing and implementing programs and activities associated with promoting wellness, providing professional health services and coordinating and processing Worker’s Compensation/disability claims. **What you'll...


  • Geneve, Schweiz Labcorp Vollzeit

    Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities? If you are looking for a company where you can gain exposure to a wide variety of science and explore a multitude of career paths across the drug development spectrum, consider...


  • Geneve, Schweiz Labcorp Vollzeit

    Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities? If you are looking for a company where you can personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view, consider...