- Work at an Industry Leading Global Contract Research Organization
- Contribute the Safety and Wellness of Patients Globally
About Our Client
- Leading global CRO with an expanding presence in APAC
- High speciality in Oncology, Rare Disease and CNS areas
- Focused largely on ICCC studies for US Biotech companies without operations in Japan
- Oversees financial performance of assigned units; develops and manages top and bottom line revenue growth and expense budgets for Safety and Pharmacovigilance.
- Provides operational and strategic leadership for Safety and Pharmacovigilance to achieve the Company's mission, creating value for customers.
- Evaluates and measures performance metrics and improves processes, as needed.
- Directs the Safety and Pharmacovigilance associates to achieve on-time quality customer deliverables, contractual project requirements, utilization goals, and profitable results.
- Identifies and develops associates to carry out required functions. Provides professional development and growth opportunities as appropriate. Is accountable for appropriate escalation and resolution of issues within the department/business unit.
- Supports business development on project proposals and approval of Safety and Pharmacovigilance budgets.
- Assists in the creation, development and nurturing of key strategic customer relationships; develops strong relationships with current and prospective customers to generate new and/or add-on business.
- Effectively leads and encourages collaboration and work sharing between offices to create a unified global Safety and Pharmacovigilance team.
- Ensures best practices and processes are followed globally.
- Maintains current professional knowledge and expertise in fields of Safety and Pharmacovigilance to serve as a basis for providing "value added" expanded company services to all appropriate customers.
- Line management responsibilities for associates. Approves course of action on salary administration, interviews, hiring, terminations, professional development, performance appraisals, job descriptions and training.
- Implements quantifiable performance standards to facilitate improvement of global efficiencies and operational excellence.
- Participates in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
- Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes.
- Participates, defines, and approves process development and improvement of departmental functions and technology.
- Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings.
- Provides oversight and governance between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
- Maintains understanding and ensures compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study plans and the drug development process.
- Participates in audits/inspections and ensures inspection readiness.
- Participates in quality investigations and ensures implementation of corrective and preventive actions.
- Performs other work related duties as assigned.
- Moderate travel may be required.
The Successful Applicant
Extensive management experience in pharmacovigilance case processing (data entry, triage, evaluation, QC, submission)
Leadership experience in pharmacovigilance. (e.g. OJT, SOP renewal, system update, managing timeline and quality)
Fluent Japanese language proficiency and upper business level English
- Prior experience in global CRO preferable
What's on Offer
- Opportunity to build leadership skills within a management position
- Opportunity to work on a large number of diverse projects to develop a broad range of IMPs
- Work on global studies at an industry leading international company
- Flexible working hours
- Flat company culture
- Highly competitive salary