Drug Safety Manager (gn)

Sie haben erste Erfahrungen im Bereich Drug Safety bzw. Pharmakovogilanz gesammelt und suchen den Sprung zu einem namhaften Biotechnologieunternehmen? Dann sind Sie genau der/ die Richtige für folgende, die ich im Augenblick betreue:


Drug Safety/ Pharmacovigilance Manager


Your Responsibilities:


Provide technical/scientific safety expertise to ensure the scientific integrity, quality and user-focus of:

*

* All relevant clinical trial activities and deliverables, including writing relevant sections of clinical trial protocols and related documents, e.g., ICFs, CRFs, the Investigator's Brochure, the Medical Monitoring Plan and the Safety Management Plan, the Statistical Analysis Plan, and the Clinical Study Reports
* Review of individual case safety reports, SUSARs and AESIs, and ensuring follow-up requests as required
* Safety data analyses and presentation of safety data for Health Authorities including Briefing Books, and BLA/MAA submission documents and responses to Health Authority questions
* Safety data presentation and analyses for e.g., Independent Data Monitoring Committees (IDMCs), internal reviews etc.
* Risk Management Plans, and implementation of pharmacovigilance and risk minimization activities including PASS, and updates to the CCSI; includes tracking the effectiveness of risk minimization measures
* Benefit-Risk Evaluations
* Investigator Initiated Trials (IITs)
* Safety Assessments for Product Quality Concerns and emerging safety issues
* Safety data in product-related publications and conference abstracts/presentations/posters

* Safety signal detection and management: core member of the product/study-specific Safety Management Teams, ensuring effective communication of information at the SMART and the Benefit-Risk Decision Board meetings, and tracking and documentation of signal management activities
* Manage the production of DSURs, including leading the kick-off meetings, writing individual sections as required, and collating the sections from other contributors, ensuring quality and timeliness of submission
* Review literature search outputs for ICSRs, safety signals, and for inclusion in DSURs etc.
* Keep up to date with technical development of tools for use in analysis, interpretation, and presentation of safety data, and use this knowledge in the development and implementation of such tools.
* Maintain an appropriate level of knowledge about relevant products and therapy areas
* Maintain awareness of developments in clinical safety and pharmacovigilance regulations and practice
* Present safety-related data, information and messages to internal and external audiences as required
* Provide technical safety expertise to ensure the scientific integrity and quality of clinical development activities and deliverables for the assigned product(s)
* Assess the impact of emerging safety data on the safety analyses and product development
* Provide state-of-the-art safety scientific methodology for safety data analysis, visualization and interpretation, collaborating closely with biostatistical colleagues

Your Requirements:

* University degree in a relevant academic field preferably in life-science, pharmacy or medicine
* At least 1 years of professional experience in the area of natural sciences and professional experience of at least one year in the field of pharmacovigilance
* Experience in working with Argus Database, MedDRA and Pharmacovigilance Regulations
* Ability to present safety data in a concise and intelligible manner
* Proven track record in time management and well-developed organizational skills
* Computer literacy and solid command of English/German, both written and spoken
* Dedication, enthusiasm, team spirit and a strong focus on quality


Haben Sie Interesse an dieser Stelle? Dann freue ich mich auf Ihre Bewerbung und ein interessantes Gespräch mit Ihnen.

Tags: Medical, drug Safety, Argus, Clinical, Pharmakovogilanz, Pharmacovigilance, pharma, biotechnologie