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Senior Safety Analyst
Senior Safety AnalystKelly Science, Engineering, Technology & Telecom • Malaysia, Malaysia
Senior Safety Analyst

Senior Safety Analyst

Kelly Science, Engineering, Technology & Telecom • Malaysia, Malaysia
1 day ago
Job description

Join to apply for the Senior Safety Analyst role at Kelly Science, Engineering, Technology & Telecom .

On behalf of our client, a global leader in consumer health, we are seeking a Senior Pharmacovigilance Analyst. In this role you will support the Local Pharmacovigilance Organization in several PV processes and compliance tasks related to the vigilance of product portfolio.

Responsibilities :

  • Manage and maintain oversight of commercial agreements across all regions.
  • Ensure commercial agreements are reviewed to assess if a Pharmacovigilance Agreement (PVA) is recommended.
  • Review the draft PVA to ensure its accuracy and support negotiation with Business Partners and execution in partnership with LSOs.
  • Ensure accuracy of PSMF Annex B Commercial Agreements listing.
  • Contribute to PVA process improvement initiatives.
  • Perform periodic Local PVA Reconciliations (ICSR) with Business Partners.
  • Support the LSOs on applicable operational tasks related to PVA.
  • Develop, update, and implement local procedures to ensure compliance with global procedures and national requirements.
  • Collaborate with the PVA Hub Lead to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.

Required Qualifications :

  • 3+ years of pharmaceutical industry experience including product vigilance responsibility role.
  • Experience in Pharmacovigilance Agreement review and related PV activities.
  • Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific / medical field.
  • Fluent communication skills in English, any additional language is a plus.
  • Ability to connect in a global organization.
  • Desired Qualifications :

  • Sound knowledge of medical terminology.
  • Seniority level

    Mid-Senior level

    Employment type

    Full-time

    Job function

    Consulting

    Industries

    Pharmaceutical Manufacturing

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    Senior Analyst • Malaysia, Malaysia