・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑外資系企業 ☑英語力が必要 ☑リモートワーク可能 ☑フレックス勤務
Associate Director / Manager, Drug Safety & PV
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:
- 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
- Implementation and maintenance of safety database and establish the processes of handling case reports with safety database.
- Interface with other 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
- Manage the courteous and good 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 PV 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 PV and safety issues to regulatory agencies, Ethics Committee (EC) and/or Institutional Review Board (IRB), Investigators, and ad hoc inquiries
- Manage Planning and conducting PMS activities for our products
- Provide input and review to key regulatory or clinical documents (i.e., clinical study reports, investigator brochures, integrated summaries of safety, development safety update report (DSUR), etc.) related to PV
- Participate in internal global PV meetings as well as joint safety meetings with partners if needed
- Collaborate with designated Contract Research Organizations (CROs) and Vendors, as assigned by the DSPV Head
- Responsible for PV inspection readiness activities and quality in collaboration with Quality Assurance
- Create local aggregate safety reports, including J-DSUR, to meet regulatory and internal deadlines.
- 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 regulations) is essential
- Drug safety database knowledge is essential
- 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
- Practical examples of end-to-end project management within Drug Safety/PV or relevant experience
- Active participation in regulatory inspections is preferred
- 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
- Working knowledge of Medical Dictionary for Regulatory Activities (MedDRA) is necessary
- At least two (2) years of experience with local aggregate safety reporting and J-RMP
- Ability to lead others without authority to move internal and external teams towards achieving goals that support our key strategic objectives
- Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
- Must have excellent communication and presentation skills (verbal and written /Japanese and English) with the ability to effectively present ideas and influence others that achieve desired results
- Demonstrated experience improving, developing, and implementing new processes
- Flexible, diplomatic, and able to effectively deal with ambiguity
- Works effectively across functions as a team player
- Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
- Excellent organizational, planning, and follow-up skills.
- An uncompromising ethical standard and level of conduct are essential.
- Successful experience in a fast-paced entrepreneurial environment
- 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
- Travel up to 10% (domestic and international), some of which will be overnight in nature
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Other