Senin, 19 September 2016

Manager, Case Management, Drug Safety - Seattle Genetics, Inc. - Bothell, WA

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Manager, Case Management, Drug Safety - Seattle Genetics, Inc. - Bothell, WA -
Obligations:

  • Helps Case Administration workforce with all pharmacovigilance actions related to Particular person Case Safety Report (ICSR) processing and reporting of hostile occasions in accordance with native laws and firm procedures

  • Accountable for mentoring, teaching and improvement of direct stories by offering an surroundings that encourages ongoing private and professional improvement

  • Chargeable for the efficiency of assigned personnel towards departmental processes, requirements and efficiency objectives and for making certain profitable completion of all coaching required for the position

  • Writer and evaluate updates and new paperwork, processes or actions to create unified and constant security-associated procedures inside the division

  • Demonstrates seamless collaboration with different departments for supply of drug security providers, course of enchancment initiatives and to offer steerage for cross-practical staff actions

  • Help with the preparation of security-associated sections and related documentation for medical and regulatory paperwork (i.e. medical research protocols, IND annual reviews, built-in summaries of security)

  • Present common oversight to the management of outsourced knowledge assortment actions with CRO’s and lead preparation, evaluation and approval of latest or up to date documentation to help standardizing outsourced actions (e.g. security management plans and budgets)

  • Beneath the steerage of the supervisor will collaborate with company companions for medical trial and post-marketing pharmacovigilance actions (i.e. pharmacovigilance agreements and security management plans)

  • Contribute to the event and implementation of the strategic course for case management useful staff and division

  • Element oriented with the power and want to work in a quick paced, workforce oriented small firm surroundings with the power to handle simultaneous priorities and difficult deadlines



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