Lead Safety Analyst

3 days ago

Tarlac City, Central Luzon, Philippines beBeeSpecialist Full time ₱3,500,000 - ₱4,500,000
Case Specialist

We are seeking a skilled Case Specialist to join our dynamic team.

The ideal candidate will possess strong analytical skills and experience in pharmacovigilance.

  • Data entry of vigilance cases into relevant databases according to established conventions is a key responsibility.
  • Quality control of vigilance cases and associated documents for safety reports requires attention to detail.
  • Medical review of vigilance cases in accordance with regulatory requirements and conventions is essential.
  • Follow-up requests on vigilance cases via phone or mail are also part of the role.
  • Pre-analysis of complex cases before data entry ensures accuracy.
  • Identification of submission requirements for safety cases is crucial.
  • Review and analysis of ICSRs downloaded from competent authorities' databases require strong pharmaceutical knowledge.
  • Performing reconciliations among partners, medical information, and quality complaints demands effective communication skills.
  • Participation in the operational implementation of new projects demonstrates adaptability.
  • Key contact for projects with support from the team leader/Activity manager/Project manager showcases leadership potential.
  • Medical review of post-marketing cases as assigned requires a deep understanding of pharmacovigilance principles.

Requirements:

  • Pharmacist or Life Sciences degree with over 3 years of experience in Pharmacovigilance is required.
  • A proven track record of working under deadlines is essential.
  • Excellent client communication skills are necessary.
  • Minimum 3 years of experience working for service providers performing QC of cases is required.
  • Strong pharmaceutical background and understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety is crucial.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment is required.

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