- Contribute to Safety Management in Global Clinical Trials
- Opportunity to Contribute to Clinical and Post-Marketing Studies
About Our Client
- Industry-leading global CRO in around 50 countries worldwide
- Wealth of experience and a proven track record in drug development outsourcing services in Japan
- Line management responsibilities including transfers, hiring, utilisation, terminations, training,
professional development, performance appraisals, time sheet approval, and employee counselling.
- Advises staff on administrative policies and procedures, technical problems, and prioritisation.
- Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on
organisational goals and company objectives.
- Monitors quality of work and efficiency of team members with contracted scope of work and Safety
- Discusses below-target project goals with senior safety management.
- Manages projects where Safety and Pharmacovigilance are the primary services.
- Reviews study budgets and expenses; ensures all study related contractual and budgeting
issues are upheld and performed.
- Works with Finance to ensure appropriate customer invoicing, where required.
- Approves project time cards and invoicing.
- Provides sponsors with scheduled project updates and reports.
- Coordinate with other internal departments and Safety functional areas to ensure timely
review and submission of reports and documents relating to safety reporting as well as
resolution of issues.
- Participates in the management of the Safety and Pharmacovigilance department with the following
- Assists in the development, review, and approval of departmental Standard Operating
- Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety
- Evaluates processes for potential improvement in efficiency and effectiveness and
recommends changes. Participates in process development and improvement of
- Works with Business Development to actively solicit new business, as needed.
- Represents Safety and Pharmacovigilance or ensure Safety representation at project team
meetings and client meetings.
- Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately
reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings.
Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure
information is consistent with the Serious Adverse Event form. Approves budget projections for the
- Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global
drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug
- Responsible for the identification, preparation, and delivery of any necessary training to Safety team
members and other departments or groups. Mentor Safety team members
- Managing resourcing's needs/issues and escalating to senior management as necessary.
- Participates in audits/inspections and ensures inspection readiness.
- Participates in quality
investigations and implementation of corrective and preventive actions.
- Performs other work related duties as assigned.
The Successful Applicant
Experience in PV operations
Deep understanding of a series of PV operations, such as monitoring, triage, inputting, QC, and adverse event reports to local regulatory authorities
Able to perform PV operations independently without supervision
English ability to able to communicate effectively with global counterparts and sponsors
Experience in using safety databases such as Argus and Aris
Aris Experience in PVnput, evaluation and / or QC functions.
Basic skills in Word, Excel and Outlook
- Line management experience
- Pharmacist, nurse, or other scientific experience is preferred
What's on Offer
- Opportunity to work on global studies
- Contribute to PMS and clinical studies