Job Description
Job Title:
Safety Manager - Japan
Department / Cost Center:
CC 219 BPV
Reports to (Job Title):
Associate Director, PV Japan
Job Code:
Location:
Japan
Date Prepared:
21 February 2025
Summary Description
State the overall function or purpose of the job.
The Safety Manager will work in conjunction with the Associate Director, PV Japan and BioMarin Pharmacovigilance (BPV) Global for activities related to pharmacovigilance in Japan to ensure that all safety activities are conducted in accordance with internal SOPs, work instructions and local health authority requirements. The Safety manager is expected to apply experience and professional expertise to conduct all of pharmacovigilance activities.
Responsibilities
List the major responsibilities of the job.
- Perform collecting, tracking, processing and submission for adverse events and other safety information from various sources based on GVP.
- Ensure all required PV regulatory reporting is performed in compliance with the local regulations.
- Perform all pharmacovigilance activities are conducted in accordance with BPV Japan's Standard Operating Procedures (SOPs), Work Instructions (WIs) and local regulatory requirements.
- Ensure all required documents related to PV activities are retained according to local regulatory requirements and internal policies.
- Support the development and periodic update of the local pharmacovigilance SOPs and WIs
- Support the development and continual improvement of pharmacovigilance processes and standard operating procedures for pharmacovigilance in Japan.
- Support BPV Global with any required local study activities
- Perform pharmacovigilance training to internal colleagues and contracted venders as required.
- Support local audit/regulatory inspections and work closely with the Associate Director, PV Japan and BPV leadership in the implementation of CAPAs following the audits/inspections.
- Escalate compliance issues in a timely manner to the Associate Director, PV Japan, BPV Global and support appropriate mitigation.
- Perform of the periodic self-inspection and temporally self-inspection based on GVP-SOP.
- Perform regular review of local regulatory requirements and/or notifications, and inform Global PV of any changes to local regulations that impact the local or global PV system.
- Participate and support JNDA activities as needed.
- Perform other activities as directed by Pharmacovigilance management (ex. RMP and Package insert creation and revision, etc.)
EDUCATION
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Degree in health sciences (nursing/pharmacy) or life sciences is preferred.
Experience
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
- Minimum of 5 years previous pharmacovigilance experience in Japan as a manager position.
- Effective communication skills in verbal and written English
- Ability to work independently but collaboratively in a matrix organization.
- Knowledge of GVP and GPSP regulations, GCP is also a plus.
- Experience with safety database desirable
- Demonstrated attention to detail for preparing and reviewing of documents.
- Experience collaborating with related departments and working in cross-functional organizations.
- Experience negotiating with vendors, and local health authorities
- Experience supporting internal GVP audits inspections by local health authorities.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
EQUIPMENT
Describe any equipment required to perform the job.
Computer work, utilizing common software programs (MS WORD, Excel, Power Point) and Safety Database (Argus)
CONTACTS
List the key positions, internal and external, with which the job incumbent must interact.
Pharmacovigilance, Global Medical Affairs, Commercial, Legal, GVP Compliance, Regulatory Affairs, and Sales & Marketing
CAREER DEVELOPMENT
List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.
To be developed.
ConfidentialPage 1
-
Safety Manager
1ヶ月前
Tokyo, Tokyo BioMarin Pharmaceutical Inc. ￥6,000,000 - ￥12,000,000 per yearThe Safety Manager will work in conjunction with the Associate Director, PV Japan and BioMarin Pharmacovigilance (BPV) Global for activities related to pharmacovigilance in Japan to ensure that all safety activities are conducted in accordance with internal SOPs, work instruction ...
-
Safety Manager
4日前
Tokyo, Tokyo Linesight ￥600,000 - ￥1,200,000 per yearWe are seeking a Safety Manager to join our team at Linesight. · This is an exciting opportunity for a highly motivated and experienced professional to lead our Quality, Health, Safety and Environment (QHSE) efforts across all projects. ...
-
Safety Manager
4日前
Tokyo Linesight OTHER￥60,000 - ￥180,000 per yearAs a Safety Manager at Linesight, you will work with highly experienced teams and gain vast industry experience that will open doors for you. You will be mentored and supported by industry leaders and given the tools to grow. · ...
-
Tokyo Ares Management ￥900,000 - ￥1,200,000 per yearJoin a dynamic team driving the future of safe, sustainable, and high-performance data centers. As the EHS Manager, you will play a critical role in supporting the design, construction, and operational phases of our Japan-based facilities—ensuring they meet the highest standards ...
-
Tokyo Taylor Hopkinson | Powered by Brunel ￥1,800,000 - ￥2,500,000 per yearAs the EHS Manager, you will play a critical role in supporting the design, construction, and operational phases of our Japan-based facilities; ensuring they meet the highest standards of safety, compliance, and reliability. · Bachelor's degree in Environmental Science, Occupatio ...
-
Tokyo Irving Knight Group ￥960,000 - ￥1,920,000 per yearEnvironmental health and safety manager based in Japan to oversee 3 plants and implement various safety measures. · Education: Degree in Engineering, Chemistry, or related field. · Experience: 2+ years experience in Environmental Health and Safety manufacturing experience. · Lang ...
-
Roppongi, Tokyo Uber ￥104,000 - ￥130,878 per yearSafety is a critical topic that resonates everywhere Uber operates. Safety never stops. We embed safety into everything we do. Our relentless pursuit to make Uber safer for everyone using our platform will continue to make us an industry leader in safety. We know that safety neve ...
-
JP, Tokyo Solventum ￥1,240,000 - ￥2,400,000 per yearSolventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. We pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives ...
-
Japan Wayve ￥5,000,000 - ￥10,000,000 per yearAs Operational Safety Manager – Japan, you will play a pivotal role in establishing and maintaining the safety framework for Wayve's expanding operations in a new country. This is a unique opportunity to shape safety culture, processes, and compliance from the ground up, directly ...
-
Tokyo Ares Management Corporation Full time￥900,000 - ￥1,200,000 per yearJoin a dynamic team driving the future of safe, sustainable, and high-performance data centers. As the EHS Manager, you will play a critical role in supporting the design, construction, and operational phases of our Japan-based facilities—ensuring they meet the highest standards ...
-
Tokyo Ares Management ￥900,000 - ￥1,200,000 per yearJoin a dynamic team driving the future of safe, sustainable, and high-performance data centers. As the EHS Manager, you will play a critical role in supporting the design, construction, and operational phases of our Japan-based facilities—ensuring they meet the highest standards ...
-
Tokyo Ares Management Corporation Full time￥600,000 - ￥1,200,000 per yearJoin a dynamic team driving the future of safe, sustainable, and high-performance data centers. As the EHS Manager, you will play a critical role in supporting the design, construction, and operational phases of our Japan-based facilities—ensuring they meet the highest standards ...
-
Tokyo Irving Knight Group ￥8,000,000 - ￥16,000,000 per yearWe are seeking an Environmental health and safety manager based in Japan to oversee 3 plants and implement various safety measures. · This individual will oversee 3 plants throughout including: Tokyo, Ichihara, Aichi. · This position is responsible for implementing corporate EHS ...
-
Tokyo Taylor Hopkinson | Powered by Brunel ￥900,000 - ￥1,200,000 per yearAs the EHS Manager, you will play a critical role in supporting the design, construction, and operational phases of our Japan-based facilities; ensuring they meet the highest standards of safety, compliance, and reliability. · Bachelor's degree in Environmental Science, Occupatio ...
-
Tokyo Taylor Hopkinson | Powered by Brunel ￥900,000 - ￥1,200,000 per yearAs the EHS Manager, you will play a critical role in supporting the design, construction, and operational phases of our Japan-based facilities; ensuring they meet the highest standards of safety, compliance, and reliability. · Bachelor's degree in Environmental Science, Occupatio ...
-
Chuo-ku, Tokyo, Japan Johnson & Johnson Innovative Medicine Full time￥3,000,000 - ￥6,500,000 per yearIn compliance with MHLW ordinance 169 Quality Management System, MHLW ordinance 135 Good Vigilance Practice, FDA , European MDD/MDR & other International Regulations,the position will perform work under general management supervision. · The Safety Management Specialist will ensur ...
-
Chuo-ku, Tokyo Johnson & Johnson MedTech ￥600,000 - ￥1,200,000 per yearThe Safety Management Specialist will perform work under general management supervision to ensure compliance with regulations and quality metrics. · ...
-
Tokyo Amazon Full time￥900,000 - ￥1,200,000 per yearThis position will lead the most critical aspect of safety in road transportation and delivery from the final delivery hub to the customer's doorstep ensuring reliable delivery to every customer. · Development and execution of annual safety and health objectives for road transpor ...
-
Tokyo Boston Consulting Group Full time￥7,500,000 - ￥15,000,000 per yearJob Summary · Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. · This role involves managing employee relations, including labor time management, holiday management, and colla ...
-
Tokyo Infotree Global Solutions ￥2,500,000 - ￥4,500,000 per yearThe Tokyo Workplace Receptionist will be the face of Tokyo office and will play a vital role in the office's success by overseeing reception, security, and office administration. · Serve as the first point of contact for employees, visitors, and vendors. · Create a welcoming envi ...
-
Tokyo, Tokyo Planet Pharma ￥400,000 - ￥800,000 per yearThe Pharmacovigilance (PV) Associate is responsible for supporting the pharmacovigilance system to ensure compliance with both local and global regulatory requirements. · Adverse Event (AE) Case Management · Receive, review, and process adverse event reports from various sources ...
