Local Safety Manager
eTeam Hong Kong
Singapore, Singapore, SG
4d ago

Job Title : Local Safety Manager

Job Description and Requirement Details

Qualification : Masters or Bachelors degree in Pharmacy or Masters degree in any life science field. Health Care Professional will also be preferred

Experience :

  • Candidate must have experience in Pharmacovigilance / Drug Safety domain like Case Processing, Aggregate Reports, RMP, PV Compliance Management
  • Candidate must be well versed with local PV regulation
  • Preferred experience :

  • Have previously liasoned with the regulatory authorities
  • 6-8 years' experience in PV domain
  • Key Words : Pharmacovigilance.

    Job Summary : This is a role that requires to maintain the local PV system in terms of structure and performance to ensure compliance with regulatory requirements and global procedures.

    This role includes not only local PV activities but also communicate and collaborate with global PV functions and will directly report to the Head of global PV function in charge of local PV system management.

    II. Key Responsibilities

    Safety Reporting (ICSR)

    Collect and report the Safety Information to Global Pharmacovigilance according to relevant SOPs.

    Perform follow-up on Safety Reports, including Pregnancy cases, as per relevant SOPs / WPs.

    Safety Reporting (Significant / Emerging Safety Issue)

    Report the significant, emerging safety issues to the Health Authority as required.

    PV Training

    Conduct local PV trainings for employees and vendors.

    Paricipate in PV trainings organized by global PV.

    Maintenance of Local PV SOP

    Develop and maintain local PV SOP to ensure compliance with the requirements.

    Aggregate Report

    Submit the required Aggregate Reports (e.g., PSUR, PBRER, and / or DSUR) to the applicable local regulatory authorities, if required.

    Risk Management Plan

    Oversight of local Risk Management Plan (RMP), if required, including generation of local RMP documents, submission to the applicable health authorities, implementation of approved RMP model.

    Local Literature Search

    Identify Safety Information detected by local literature search and report it to global PV.

    Interface with Other Functions

    Safety information reconciliation with relevant team such as Product Quality Complaint and Medical Inquiries.

    Work on PV-related CAPA management.

    Regulatory Intelligence

    Maintain current knowledge of all local regulatory PV requirements in the Territory.

    Others

    Manage responses to PV-related queries from health authorities.

    Manage PV audit / inspection readiness and responses in collaboration with relevant global functions.

    Interaction with Global PV

    Escalate potential gaps or issues to global PV.

    Participate into the activities organized by global PV.

    Report this job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Apply
    My Email
    By clicking on "Continue", I give neuvoo consent to process my data and to send me email alerts, as detailed in neuvoo's Privacy Policy . I may withdraw my consent or unsubscribe at any time.
    Continue
    Application form