求人情報詳細

Drug Safety & Pharmacovigilance Associate Director

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掲載日:2019/10/24

※採用企業名は会員のみ表示されます。

年収:800万円 〜 1,400万円

勤務地 東京
業種 メディカル > 医薬品メーカー
職種 メディカル > 臨床開発・治験関係・CRC・CRA・PV

仕事内容

Job Summary
This role is mainly responsible for participating in the Drug Safety and PV operational activities, including the planning of PMS, EPPV, and conducting these activities by managing outside vendors.
Responsibilities will include, but are not limited to, the following:
・ Planning and conducting PMS activities for Our Company products
・ Manage the relationship with Pharmacovigilance providers and internal personnel
・ Contribute to the development, production, and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the pharmacovigilance activities
・ Collaborate with global safety physicians, and other functional groups in identification, analysis for contributing to development & maintenance of product safety profile
・ Support and/or draft regulatory inquiry responses related to pharmacovigilance /safety issues to regulatory agencies, EC/IRB, Investigators, and ad hoc inquiries
・ Provide input and review to key regulatory or clinical documents (i.e., clinical study reports, investigator brochures, integrated summaries of safety, DSUR, etc.) related to pharmacovigilance
・ Participate in internal global pharmacovigilance meetings as well as joint safety meetings with partners if needed
・ Provide oversight of designated CROs and Vendors, as assigned by the Head of Pharmacovigilance
・ Responsible for oversight for PV inspection readiness activities and quality in collaboration with Our Company Quality Assurance
・ Review and or Authorize high-quality aggregate safety reports, including DSUR, PBRER, or PADER, to meet regulatory and internal deadlines.
・ Ensure all regulatory safety documents are processed and submitted according to
regulatory requirements and timelines
・ Critically draft or review documents produced for regulatory agency safety inquiries in
terms of scientific content and alignment with company position, clarity, accuracy, and
consistency and facilitate document review by other contributors
・ Participate in ongoing safety data review and analysis for products
・ Interface with other Our Company functional groups such as Regulatory Affairs, Clinical
Development, Medical Affairs, Quality, business units, as needed
・ Contribute to on-going process enhancement for safety operations such as developing
standard procedures and templates

事業内容

本 社	米国バージニア州リッチモンド
設 立	1988年
インスリン抵抗性に関連した代謝性疾患及び内分泌疾患治療の医薬品開発をめざす新進のバイオ企業です。

必要な経験・能力

・ Bachelor's, Master’s or Doctorate level degree in pharmacy, nursing, or other
healthcare-related profession or life sciences required.
・ Additional Master’s in Public Health (MPH) or MBA is a plus

・ Minimum five (5) years in Drug safety/Pharmacovigilance in pharmaceutical
industries setting with both investigational and marketed products
・ Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations
governing both Safety reporting and processing for clinical trial environments
(including ICH/CIOMS, Clinical development methodology and knowledge of
Clinical Trial guidelines (GCP) and regulation) is essential
・ Practical examples of end-to-end project management within Drug Safety/PV or
relevant experience
・ Active participation in regulatory inspections is a plus
・ At least two (2) years of experience with, aggregate safety reporting, safety
surveillance, signal management and/or Risk management
・ Ability to review and or prepare, scientific or regulatory documents, from large
volumes of scientific information
・ Knowledge and understanding of national & international PV and regulatory
guidelines
・ Drug safety database knowledge preferred
・ Working knowledge of MedDRA dictionary is necessary
・ Knowledge of Individual Case Safety Reports (ICSR) management processes
including case receipt, case processing, medical review, and regulatory submission
・ Ability to read and collate scientific and medical literature is also required
・ Knowledge of pharmacoepidemiology preferred

Skills/Capabilities
・ Ability to lead others without authority to move internal and external teams towards
achieving goals that support Our Company key strategic objectives
・ Demonstrated experience improving, developing and implementing new processes
・ Strong communication skills with the ability to effectively present ideas and influence
others that achieve desired results (verbal and written / Japanese and English).
・ Flexible, diplomatic and able to effectively deal with ambiguity
・ Works effectively across functions as a team player
・ Successful experience in a fast-paced entrepreneurial environment
・ Highly organized with strong attention to detail, clarity, accuracy, and conciseness

Other
・ Individuals must demonstrate the ability to interact successfully in a dynamic and
culturally diverse workplace
・ Non-smoker
・ Travel approximately 20% (domestic and international)

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業界経験年数:3年~5年    勤務地:大阪
業種:メディカル
職種:メディカル

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