Drug Safety Operations Manager

Vor 5 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.

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