Drug Safety and Pharmacovigilance - バイオ医薬品会社

Location: Tokyo
Contract Type: Permanent
Salary: ¥6000000.00 - ¥10000000.00 (年収)
Specialization: Life Science (Medical Devices / Pharmaceutical / Chemical / Healthcare / Agriculture / Livestock),
Sub Specialization: QC / QA,
Contact: Yoshiko Kumakura
Reference: JO-2201-466898

Drug Safety and Pharmacovigilance

[Company Description]

This role is mainly responsible for participating in the Drug Safety and Pharmacogivilance activities as follows:
1. Daily operational works on Pharmacovigilance (PV) and Post-Marketing Study (PMS) activities,
2. Training relating to PV and PMS activities,
3. Quality control and assessment on PV and PMS activities,
4. Record management on PV and PMS activities,
5. Vendors/Temporary staff management, and
6. Supporting work for communication with regulatory authorities.

Responsibilities (Essential Role Responsibilities):
・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 company's 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 relationship with PV 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
・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
・Provide oversight of designated Contract Research Organizations (CROs) and Vendors, as assigned by the PV Head
・Responsible for oversight for PV inspection readiness activities and quality in collaboration with company's Quality Assurance
・Review and or Authorize high-quality aggregate safety reports, including DSUR, Periodic Benefit-Risk Evaluation Report (PBRER), or Periodic Adverse Drug Experience Report (PADER), to meet regulatory and internal deadlines.

・Minimum five (5) years in Drug safety/PV 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 case report 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
・Ability to lead others without authority to move internal and external teams towards achieving goals that support company's key strategic objectives
・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
・Successful experience in a fast-paced entrepreneurial environment
・Highly organized with strong attention to detail, clarity, accuracy, and conciseness
・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

[Language Requirement]
・English Language level: Business level
・Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)
・Work permission in Japan required

6〜10 million JPY
※Experiences and skills will be considered

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.

Reference: JO-2201-466898
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance