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| Safety Compliance and Training Manager |
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Within this role you shall contribute to building Medical Excellence on safety management for global clinical trials or non-interventional studies within Global Medical Affairs (GMA).
Your primary accountability will be to ensure continuous improvement through innovation, consistency, standardization, issue management and training across the Medical Affairs functions.
Utilizing your dynamic leadership skills and broad experience, you shall guide the implementation of quality oversight and functional training programs to ensure the GMA activities are conducted in accordance to the Roche SOPs, guidelines / policies and international regulations on safety.
In addtition you will:
Develop high quality and innovative training programs for GMA staff (International Medical Leaders and International Clinical Trial Managers primarily)
Issue management and quality oversight regarding risk areas identified from audits and mock inspections regarding the safety reporting process in Phase 3b/4 clinical trials
Ensure that GMA Medical staff and Study Management Teams are aware of their responsibility providing oversight to ensure the safety-related activities are completed during all phases of a clinical trial or non interventional study
Review and approve safety related documents (Directive, Policy, SOPs and guidelines) as Subject Matter Expert for GMA
Liaison with other safety departments within the Roche organization: Drug Safety, EU QPPV office, Safety Quality Risk Areas
Leadership of Change Management initiatives to optimize pharmacovigilance processes at the affiliates |
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Bachelors Degree (life sciences or equivalent)
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10 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Basel |
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You have a university degree preferably in life sciences or equivalent and have worked at least five years in the pharmaceutical industry, preferably in a Medical Affairs and/or Drug safety organization.
To be successful in this role you will need an excellent knowledge and understanding of clinical trials processes and medical communications.
You will also have knowledge of international (FDA, Volume 9A) regulatory documents as well as ICH guidelines and international/national GCP requirements.
You should
have the ability to acquire knowledge and analyze information effectively
be experienced at working independently and as part of a compliance team
have exceptional oral and written communication (in English) and networking skills
have a track record of successful influencing, process improvement and change management.
Contact HR: Martin Erschbamer, Phone: +41 (0)61 68 85977 |
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At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site. |
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Roche (F. Hoffmann-La Roche AG)
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