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.

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• 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.