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Drug Safety/Physician
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Marketing, Support
Projektbeschreibung
eDrug Safety Expert/Safety Physician
Assists in the collection, assessment and processing of adverse events reported during clinical trials or through post-marketing surveillance to ensure compliance with worldwide regulations and guidelines for reporting.
Reviews cases to determine seriousness, expectedness and causality, as applicable.
Assists in completion of cases entered into the safety database. Prepares summary safety reports for internal and external use.
Understands relevant safety implications of changes in regulatory procedures and guidelines. Possesses extensive knowledge or ability based on research and similar positions occupied in this particular area.
Relies on extensive experience (more than 10 years in this field), and judgment to plan and accomplish goals.
Will work on tasks assigned by his/her manager and by the safety lead (SL) or equivalent for the product(s) which can include:
" input into the safety management of assigned products, which includes signal detection, signal assessment, benefit risk evaluation, analysis of individual cases,
" preparation of aggregate reports,
" input into safety risk management deliverables,
" responding to requests from health authorities.
Major Accountabilities
" Identify risks and propose corrective actions in moderately complex situations
" Write and review responses to questions from competent Authorities
" Fulfill required responsibilities of project team member and when delegated as project team leader (as determined by project governance: may participate in study team)
" When applicable, provide safety input and review to aggregate reports and ad hoc safety reports
" When applicable provides input into pharmacovigilance process improvement (eg, assigned member of process workstreams)
" Review and provide safety input for relevant clinical or regulatory documents for assigned products (IB, protocols,
RMP, SmPC, US PI, PIL, EMA article 31s, FDA field alerts, and OSS Medical Assessments, etc)
" Provide support to SL for GLC and PST activities
" Lead ad hoc pharmacovigilance projects
Expertise
Strong scientific/medical background
" Knowledge and understanding of applicable regulations in pharmacovigilance and clinical development
" Ability to extrapolate from this knowledge in new situations
" Skilled at operating in cross- cultural team environment
" Able to give presentations to interdepartmental audiences
" Inspires confidence through influencing skills and technical ability
" Able to see underlying or hidden medical problems and proactively take actions
Management and Leadership
" Takes courageous decisions (calculated risks) to meet his/her objectives Leads by influence & operates through networks
" Mobilizes relevant colleagues, business partners and other stakeholders when facing obstacles
" Demonstrates accountability for decisions and actions taken
REQUIREMENTS
Minimum 5 years relevant experience
Minimum 3 year experience in Drug Safety
Excellent English scientific writing and communication skills
Assists in the collection, assessment and processing of adverse events reported during clinical trials or through post-marketing surveillance to ensure compliance with worldwide regulations and guidelines for reporting.
Reviews cases to determine seriousness, expectedness and causality, as applicable.
Assists in completion of cases entered into the safety database. Prepares summary safety reports for internal and external use.
Understands relevant safety implications of changes in regulatory procedures and guidelines. Possesses extensive knowledge or ability based on research and similar positions occupied in this particular area.
Relies on extensive experience (more than 10 years in this field), and judgment to plan and accomplish goals.
Will work on tasks assigned by his/her manager and by the safety lead (SL) or equivalent for the product(s) which can include:
" input into the safety management of assigned products, which includes signal detection, signal assessment, benefit risk evaluation, analysis of individual cases,
" preparation of aggregate reports,
" input into safety risk management deliverables,
" responding to requests from health authorities.
Major Accountabilities
" Identify risks and propose corrective actions in moderately complex situations
" Write and review responses to questions from competent Authorities
" Fulfill required responsibilities of project team member and when delegated as project team leader (as determined by project governance: may participate in study team)
" When applicable, provide safety input and review to aggregate reports and ad hoc safety reports
" When applicable provides input into pharmacovigilance process improvement (eg, assigned member of process workstreams)
" Review and provide safety input for relevant clinical or regulatory documents for assigned products (IB, protocols,
RMP, SmPC, US PI, PIL, EMA article 31s, FDA field alerts, and OSS Medical Assessments, etc)
" Provide support to SL for GLC and PST activities
" Lead ad hoc pharmacovigilance projects
Expertise
Strong scientific/medical background
" Knowledge and understanding of applicable regulations in pharmacovigilance and clinical development
" Ability to extrapolate from this knowledge in new situations
" Skilled at operating in cross- cultural team environment
" Able to give presentations to interdepartmental audiences
" Inspires confidence through influencing skills and technical ability
" Able to see underlying or hidden medical problems and proactively take actions
Management and Leadership
" Takes courageous decisions (calculated risks) to meet his/her objectives Leads by influence & operates through networks
" Mobilizes relevant colleagues, business partners and other stakeholders when facing obstacles
" Demonstrates accountability for decisions and actions taken
REQUIREMENTS
Minimum 5 years relevant experience
Minimum 3 year experience in Drug Safety
Excellent English scientific writing and communication skills
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Sonstiges