Beschreibung
Pharmacovigilance Specialist (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM+
Main tasks:
- Ensure that, in collaboration with the Quality & Compliance Group, operational processes and roles, according to the operational model, are followed
- Identify the needs of SOP/WI of Medical Safety Department and insure their writing and implementation
- Collaborate with the external service providers delivering pharmacovigilance services, up to industry standards as per regulations and guidelines, including quality control of the ICSRs, and any other Safety related documents
- Perform medical review and provide medical advice on safety-related aspects associated with the assigned compounds and Chair regular meetings of the Safety Management Teams overseeing the compound Safety profile
- Review and validate ICSRs from ongoing clinical studies and collaborate with the External service provider to process the ICSR, ensure expedited reporting requirements are met
- Review of a study-specific Safety Project Plan for assigned clinical studies across the portfolio, and ensure oversight on the activities executed in view of such Safety Plan
- Contribute to the creation and review of the Safety parts of certain clinical study related documents - Clinical Study Synopsys/Protocols and Clinical Study Reports
- Contribute to the creation and review of the Safety parts of certain compound related documents - Investigator’s Brochure and dRMP
Main qualifications
- Profound experience in similar position
- Broad experience in drug development, in a biotech or pharmaceutical company
- Experience in a matrix environment, interaction with stakeholder with different back ground and ability to adapt to corporate culture are essential
- Broad knowledge of pharmacovigilance needs within a drug development environment
- Solid knowledge in Good Vigilance Practice (GVP)
- Sound knowledge of general drug development process
- Sound knowledge of ICH (International Council on Harmonisation of Technical Requirements), GCP (Good Clinical Practice) and other regulatory requirements applicable in the pharmacovigilance domain
- Excellent team player, able to deliver in a tight deadlines and in a demanding environment
- Very good technical and organizational skills
- Excellent writing and communication skills both towards team members within the company as towards external contacts
- Ability to negotiate
- Fluency in English
Main advantages:
- Challenging and varied tasks in a promising and innovative industry
- Prospect of project extension
- Dynamic and innovative market environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Nadja Jacqueline Sigwart
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