Associate Safety Director (m/f/d)
Responsibilities
- Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRE)
- Responsible for signal detection and management activities. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (incl, product quality) or in response to Regulatory Authority requests
- Provide expert contribution to the development of the product safety strategy
- Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
- In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed
Profile
- Qualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous
- Work Experience of drug development, experience in the pharmaceutical or related industry
- Experience in drug safety/PV or a closely related field
- Minimum level required Associate Safety Director
- IT/Tool Skills good excel/word/powerpoint skills; able to extract data from the Safety Database and apply complex data analysis
- Language Skills: Fluent in English, both written and verbal
Benefits
- A very renowned company
- Interesting assignments at renowned national and international companies
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in 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 experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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