Pv/ra/qm Specialist

Selangor, Malaysia

Job Description


Job Responsibilities:

  • Staying informed about regulatory requirements, ensuring compliance, and communicating with global, regional, and local teams.
  • Handling safety event reviews and submissions to both Global Pharmacovigilance and local health authorities.
  • Managing registration dossiers for regulatory approvals and maintaining local licenses.
  • Evaluating change requests and their regulatory impact.
  • Reviewing product labeling for compliance with branding and regulations.
  • Leading or supporting local Good Distribution Practice (GDP) inspections.
  • Assisting in addressing deviations and product complaints while monitoring their resolution status.
Your Requirements:
  • Bachelor\'s Degree in Pharmacy, Life Sciences or equivalent with minimum 2 years experiences in RA and/or PV in pharmaceutical industry. Malaysian licensed Pharmacist preferred.
  • Strong organizational and process management skills. Able to multi-task effectively.
  • Proven ability to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
  • Teamwork and collaboration with cross functional teams.
  • Excellent verbal and written communication skills in English.

JAC Recruitment

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Job Detail

  • Job Id
    JD1004721
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    54000 - 66000 per year
  • Employment Status
    Permanent
  • Job Location
    Selangor, Malaysia
  • Education
    Not mentioned