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Position	Senior Head of Safety- Switzerland
Company	Key People Ltd
Location	TBC
Country	Switzerland
Job Description	Senior Head of Safety Job Description : Responsible for the management of a team of Pharmacovigilance Leaders, and/or Safety Leaders of IMS Oncology. Oversees medical and safety aspects on assigned own, and on drugs of team members of own Unit. Supervises and leads scientific approach of assigned PVLs and/or Safety Leaders in analysis and management of potential risks related to the assigned drugs. Is accountable for compliance in signal detection, analysis and documentation of safety signals and appropriate risk management within assigned drug group. Functions as Safety Leader for one assigned product. 1. Day-to-day management of assigned IMS team members and assigned mentee(s) 2. Prepares objectives and evaluates related performance for the assigned members. 3. Provides guidance on, and initiates/maintains productive cross-functional medical safety collaborations internally with colleagues from Global IMS line functions, and Business Unit Oncology (OBU) functions such as Drug Regulatory Affairs, Statistics, Pharmacoepidemiology, Legal, or other related departments, and externally with Expert Panels and other external scientific contacts. 4. Ensures that the safety risks within our clients projects/products are identified promptly, and appropriately analyzed, monitored and handled within the assigned group. This includes oversight of use of signal detection tools such as SIGNS and other applications and/or of safety intelligence sources for potential product signals. 5. Ensures that medical safety signals from aggregate data are communicated appropriately,including documents such as Safety Profiling Plans, Risk Management plans, and supporting documents for label changes. 6. Leads and/or coordinates as necessary the preparation of medical safety data/information for our clients boards, MSRB, SIDGET, Integrated Safety Management, crisis management teams, and Health Authorities for safety issues of assigned group of drugs. 7. Provides guidance on the clinical content of safety reports across the assigned drugs of the OBU , including adverse event reports, assessment on the medical conditions and the implications of our clients drugs in reported side effects, safety analyses and conclusions in the documentation of comprehensive safety reviews, individual clinical trials or submission documents for worldwide approval or license renewal. 8. Ensures common global processes and guidelines for safety assessment, analysis, and compliance within the assigned group, including guidance for coding and the assessment of causality/expectedness for adverse event reports, and training of team members in cooperation with train-ing department, if applicable. 9. Ensures standardized, quality, and comprehensive safety documentats on the experience within our clients projects/products within the group, including adverse event reports and responses to health professionals and regulatory authorities. 10. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities. 11. Serves as first-line approval for all safety reports prepared by the BSLs and PVLs within the group. Minimum requirements : Education (minimum/desirable): • Medical Degree absolutely required. • Specialty Board Certification desirable. Languages: English and reliable understanding in another major language (e.g. French, German, Spanish) desirable. Experience/Professional requirement (at least): • 3 years clinical experience postdoctoral • At least 7 years in drug development in a major pharmaceutical company (of which 5 years in a global position), including 5 years in safety at an operational or medical position- • Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information. • Experience in leading cross-functional, multi-cultural teams • Experience with (safety or others) issue management • Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications • Desirable: Management experience (2- 8 direct reports) For immediate consideration, please email your CV with salary requirements
Company Profile	Key People is a recruitment consultancy with a reputation for providing good value that’s been built up over 15 years. Clients come to us for three main reasons: > We achieve results faster > Our candidates really are a cut above > We add greater value We think it’s because we’re a private company driven by clients, not by shareholders. We focus on a number of key industry sectors and have specialist teams, each dedicated to one specific market. Over the years, we’ve created an extensive network of invaluable industry contacts. This means we know exactly where to gain access to the very best people – talented professionals with specialist skills we know you’ll want to meet. For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe and also many around the globe, who choose to recruit through Key People, so you’ll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you’ll get the chance to work for some prestigious, blue-chip organisations.
Job Type	Full Time
Salary	Upto 0 € Per Month
Skills Required	Drug Safety
Reference	kpgdsjip03
Posted On	02 March 2010
Last Date to Apply	02 April 2010
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