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Associate Director Patient Safety Physician Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
WHAT YOU'LL BE DOING:
- The role holder provides medical leadership as either an expert lead for a number of drug projects that ensures effective collaboration between physicians and teams.
- Will develop and build, or act as a safety medical expert, within a cross-functional multi-skilled team comprised of experts across multi-disciplinary project teams.
- Accountable for US surveillance activities
- Ensures delivery of contributions as a regional expert supporting Patient safety (PS) assessments and research for the US business
- Provides US Patient Safety expertise in the development of strategy for FDA specific (non submission) documents such as regulatory responses
- Oversees or provides expert technical support to clients on a regional and potentially global basis
- Develops, builds or acts as a specialist within a cross-functional, multi-skilled team from a number of scientific disciplines
- Provides input and member of Risk Evaluation and Mitigation teams
- Litigation safety support
- Safety input into US Issue management
- Provide US PS input to global safety teams (SaMTs)
- Responsible for the content of the Safety Sections of the US Prescribing information
- Manages or provides expert guidance from the US business perspective on US clinical trials
- Represents US Patient Safety at external events
- Networks with colleagues and experts, providing consultancy in own area of expertise and serving as a resource for others by sharing experience within and beyond project team and function
- Keeps own knowledge of best practices and new relevant developments up to date
- Ensures that all work is carried out with regards to standards and external regulations
- Closely collaborate with other relevant stakeholders in the global and US business (including regulatory, medical affairs, Real World Evidence, legal)
- Ensures efficient and effective leadership and management of project information, strategy, quality standards, and integrity of information interpretation (sr. Level)
WHAT YOU NEED TO BRING TO THE TABLE:
- MD or equivalent degree from US or reputable foreign medical university
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals
- Two (2) or more years of drug development and/or pharmacovigilance experience obtained while working in the pharmaceutical industry and/or academia
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Krista Leach
IF THIS SOUNDS LIKE YOU, APPLY NOW!/APPLY NOW!
Yoh, a DayJ2W: CLINICAL
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Gaithersburg, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges