Pharmacovigilance Specialist

  • الراتب:
    قابل للتفاوض
  • نوع الوظيفة:
    دوام كامل
  • تاريخ النشر:
    5 أشهر مضت
  • التصنيف:
    وظائف طبية
  • آخر موعد للتقدم:
    2022-07-23
  • اللغات:
    العربية, الانجليزية
  • الجنس:
    الجنسين

Job Purpose :

This role is responsible for supervising the following activities in selected MENA countries: PSURs and RMPs, safety data exchange agreements (SDEAs), SDEA Matrix, safety case processing and reporting, labeling safety review, risk assessment of defects and complaints, updates of local PV procedures and local PSMF, audits and inspections, and safety review of clinical studies, in coordination with Local PV teams and PV service provider(s) to ensure compliance with good pharmacovigilance practice (GVP), PV regulations and regulatory requirements, PV policies and procedures, and SDEAs with third parties.

  • Supervise the preparation and submission of aggregate reports in selected MENA countries.
  • Coordinate the preparation, review, and submission of aggregate reports, RMPs, or national displays, including any aRMMs, for selected MENA countries.
  • Coordinate the preparation and review of SDEAs and review responses to partner questionnaires, updates of the SDEA Matrix, and the MENA Regulatory Requirements Reporting Table (RRRT) Matrix.
  • Coordinate the product labeling safety review and health risk assessment of product quality defects and complaints in selected MENA countries.
  • Assist in the creation and update of regional and local PV procedures, Local PSMF and National PSSF(s) for selected countries.
  • Supervise safety case processing and reporting from all sources and local literature monitoring in selected MENA countries.
  • Assist in the coordination of PV audits on MENA affiliates and follow-up of PV-related CAPAs for selected MENA countries.
  • Contribute to the safety review of clinical study protocols, data management plans, statistical analysis reports, interim reports, and clinical study reports (CSRs) for studies in MENA and EU.

QUALIFICATIONS – Experience & Skills :

  • Minimum: Medicine or Pharm D or Pharmacy or B.A./B.S. degree
  • Preferred: NA

EXPERIENCE :

  • Minimum: 4-7 years of related industry experience of which 2 years in pharmacovigilance
  • Preferred: NA

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