Drug Safety Case Manager (m/f)

REFERENCE NUMBER:

381657/29

MY DUTIES:

-Work in a team-oriented environment and be responsible for the management
-Of adverse event information associated with investigational and post-marketing products in compliance with applicable global regulations and SOPs and guidelines
-Case processing, such as triaging, data entry, coding of AE information, quality control and submission of expediting AE reports to health authorities for investigational and post-marketing products in the safety database
-Perform case prioritisation according to relevant SOPs to ensure timely submission of expediting reports to regulatory authorities
-Screen medical literature from various literature databases to identify published case reports and prepare literature AE case reports for case processing
-May act as Global Drug Safety representative/contact person for Clinical Trial Team members for specific clinical trials
-Collaborate closely with the Drug Safety Physician responsible for investigational products in clinical trial operational activities and support the Clinical Trial Team during the set-up of new clinical trials
-Manage the clinical thai set-up in Argus and contribute to trial specific AE coding guidelines and develop customized SAE form
-Coordinate SUSAR notification process to investigators and Ethics Committees
-Prepare/review appropriate safety agreements/contracts with Contract Research Organizations when needed

MY QUALIFICATIONS:

-University degree in life sciences (e.g., pharmacy, nursing) or equivalent education in health related field
-Formal training in health-related field and/or experience in safety data processing
-Profound experience in safety or clinical data management
-Knowledge of medical terminology and general understanding of disease processes
-Excellent organisational and problem solving skills, interpersonal skills, and the ability to work under pressure and meet short timelines
-Fluency in English (verbal and written), knowledge of German or French is an advantage
-General knowledge of coding thesauri and medical/drug dictionaries

MY BENEFITS:

-A very renowned company
-Interesting tasks in a multinational environment
-A city with a high quality of life that perfectly embraces both modern and traditional values

ABOUT HAYS:

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
Svenja Weiß

Reference number
381657/29

Contact
E-Mail: [email protected]