転職・求人情報の詳細をご覧になる場合は会員登録（無料） が必要です
| 部署・役職名 | Drug Safety ＆ Pharmacovigilance Associate Director |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 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 |
| 労働条件 | 労働条件の一部につき、求人票には記載せず面談時にご案内致します。 |
| 応募資格 |
【必須（MUST）】 • Bachelor's, Master’s or Doctorate level degree in pharmacy, nursing, or otherhealthcare－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） |
| 更新日 | 2019/10/24 |
| 求人番号 | 1155621 |
採用企業情報
- 企業名は会員のみ表示されます
- 会社規模1-30人
この求人の取り扱い担当者
-
- ?
- ヘッドハンターの氏名は会員のみ表示されます
会社名は会員のみ表示されます
-
- メディカル
-
- 多くの製薬企業から大変高い評価・信頼を頂いております。製薬業界勤務経験を活かしご転職のアドバイスをしております。
- (2015/07/09)
