P2257 - Safety Systems Administrator
vor 1 Tag
**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally._
- At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target._
For our R&D Pharmacovigilance organization based at our Headquarters in Lausanne, we are looking for a
**Safety Systems Administrator**
**Your responsibilities will be but not limited to**:
The Pharmacovigilance System administrator secures appropriate support to the Clinical safety and Pharmacovigilance systems and is accountable for administering and maintaining the different safety systems
**Main responsibilities**:
- Is the administrator of the safety database: manages system access requests (internal and external), receives and responds user questions/issues and coordinates resolution with the safety database vendor, trains internal users and oversees external users training, conducts routine and adhoc data extraction, handles safety database upgrades and bi-yearly MedDRA upgrades, ensures appropriate change control processes, ensures vendor oversight
- Is the administrator of the signal management documentation system: manages system access requests, receives and responds user questions/issues and coordinates resolution with the vendor, oversees user training, conducts routine and adhoc data extraction, manages upgrades and change control processes, ensures the coordination with the vendor
- Is the internal referent person for Eudravigilance and XEVMPD
- Creates and maintains quality documents (including SOPs, manuals, training material) linked to these different safety management systems, participates in Computer System Validation (CSV) activities together with IT and QM
- Creates and maintains training records for these systems
- Evaluates proposed project ideas/softwares modifications through technical impact analysis and estimated business value to contribute to decision-making-and provides guidance and leadership as needed
- Responsible for supporting audit/inspections readiness and participates as needed
- Is the Trial Master File referent of our team
**Requirements**:
- Bachelor’s degree in related field or equivalent years relevant industry experience)
- Previous experience working in pharmacovigilance in the pharmaceutical industry or CRO
- Experience in a systems operations support role within safety/pharmacovigilance
- Experience with validated document management systems is an asset
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork
- Excellent interpersonal, written and verbal communication skills
- Excellent computer, organizational and communication skills
- Demonstrates strong leadership skills and experience
**Benefits**
**Debiopharm offers employees**:
- International, highly dynamic environment with a long term vision
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
- Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm._
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