PV Mgr

Japan Permanent Foreign Multinational
  • 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

Job Description

  • 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
    Management Plan.
  • 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
    actions:
    - Assists in the development, review, and approval of departmental Standard Operating
    Procedures (SOPs)
    - Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety
    Reporting Plan.
    - Evaluates processes for potential improvement in efficiency and effectiveness and
    recommends changes. Participates in process development and improvement of
    departmental functions.
    - 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
    project.
  • 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
    development process.
  • 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
Contact
Ed Marsden
Quote job ref
4156480
Phone number
+813 6832 8981

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
4156480
Company Type