Drug Safety Medical Manager

Vor 4 Tagen

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.

  • Drug Safety Medical Manager

    Vor 4 Tagen

    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...

  • Global Medical Affairs Lead

    vor 2 Stunden

    Geneve, Schweiz Axepta SA Vollzeit

    Our client, a growing and global biotech company located in Geneva canton is looking for a Global Medical Affairs Lead to manage a small team and work actively on the global medical affairs strategy for their key products. **YOUR RESPONSIBILITIES**: - Lead and manage a small team of Global Medical Affairs Managers - Ensure the global medical plan and...

  • Global Medical Director

    Vor 2 Tagen

    Geneve, Schweiz Compass Life Sciences Vollzeit

    Compass Life Sciences have partnered with a groundbreaking biotech that is advancing novel therapeutics for chronic Neurological disorders and autoimmune diseases such as Multiple Sclerosis. Founded in 2006, our client has grown its business on cutting edge science that has helped identify novel approaches that treat autoimmune diseases by using biology to...

  • Laboratory Supervisor in Safety Testing

    Vor 4 Tagen

    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 Lead

    Vor 6 Tagen

    Geneve, Schweiz Global Antibiotic R&D Partnership (GARDP) Vollzeit

    **Overall Purpose**: The Medical Lead will deliver the medical strategies and lead execution of plans for the clinical development and delivery of new and existing antibiotics as treatments for priority drug resistant infections aligned with a GARDP disease area strategy. He/she will be the medical lead for an R&D drug project led by an overall project lead...

  • Manager, Safety Management Systems

    Vor 6 Tagen

    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...

  • Medical Affairs Manager

    Vor 6 Tagen

    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 1 Woche

    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...

  • ERP Project Manager

    Vor 2 Tagen

    Geneve, Schweiz Arobase Vollzeit

    **INTRODUCTION**: Here is the chance to contribute actively to an international NGO based in Geneva! You will have the opportunity to work in a rich, complex and international environment to deploy new solutions as: **ERP Project Manager - Medical Apps**: **ASSIGNMENT DESCRIPTION**: - Coordinate and manage the Odoo ERP deployment and medical apps...

  • Intern, Safety Risk

    Vor 6 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...