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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 opportunity to drive the global Drug Safety activities within a fast-growing company, acting both as a strategic leader and hands-on expert.
Your main responsibilities are as follows:
- Lead, support and develop the Drug Safety team (3 direct reports, 4 people in total)
- Establish and maintain the Pharmacovigilance System in accordance with EU and international standards
- Work closely with department head and QA/Regulatory/Clinical development to maintain an effective and compliant system for monitoring the safety profile of company’s products
- Ensure that the EU QPPV as well as local and regional QPPVs (PV Community) are able to fulfil their role and function
- Oversee the activities of contract research/service organizations and individuals, contracted to perform drug-safety and pharmacovigilance activities
- Act as a key contact point together with EU QPPV for audits and inspections
- Act as coordinator of the Product Benefit Risk Committee (PBRC) and as key contact for company’s Management Boards
- Act as deputy of Drug Safety Medical Manager and Drug Safety Operations Manager
- Provide PV expert functional advice and assistance to other functions as needed
- Oversee the activities for monitoring adverse event reports for potential drug-safety related issues and provides recommendations when potential issues are identified
- Lead PV process constant improvement (Signal detection, Case processing, Medical Writing, Literature review) together with Subject Matter experts
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 10 years of experience in data analysis, signal detection, benefit/risk evaluation, aggregate safety reports and/or literature review
- Demonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues
- Excellent knowledge of EU, Swiss and international regulations (ICH, EMA GvP, Swissmedic and FDA regulations)
- Experience in team management and proven leadership skills
- Fluency in English with good oral skills in French
To be successful in this role, we are looking for an experienced leader and Drug Safety expert. Feeling comfortable in a fast-paced environment, you describe yourself as solution-oriented person with a client-centric mindset, who likes to act in an entrepreneurial and innovative manner. Thanks to your communication skills, you easily interact with different cross-functional stakeholders and quickly establish collaborative relationships. Furthermore, your strategic thinking enables you to examine and understand issues from multiple points of view and propose/implement improvements with a pragmatic and proactive approach.
**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.
