Vigilance Specialist

2 weeks ago

Davao City, Davao, Philippines beBeeMedicalReviewer Full time ₱1,500,000 - ₱2,500,000
Medical Reviewer

We are seeking a skilled Medical Reviewer to join our dynamic team. As a Medical Reviewer, you will play a crucial role in the activities performed in our Hub.

  • Enter vigilance cases into relevant databases according to established conventions and regulatory requirements.
  • Verify the quality of vigilance cases and associated safety reports, ensuring compliance with GVP and GCP regulations.
  • Conduct medical reviews of vigilance cases in accordance with relevant conventions and regulatory requirements, applying strong pharmaceutical knowledge and pharmacovigilance principles.
  • Follow up on vigilance cases via phone or mail, communicating effectively with clients and partners.
  • Pre-analyze complex cases prior to data entry, identifying submission requirements for safety cases and preparing ICSR/MLM filters.
  • Determine submission requirements for safety cases and identify requirements for preparing ICSR/MLM filters, ensuring timely and accurate submissions.
  • Review and analyze ICSRs received from competent authorities, applying deep knowledge of pharmacovigilance principles and adverse event reporting.
  • Perform reconciliations between partners, medical information, and quality complaints, maintaining high-quality standards and attention to detail.
  • Participate in the operational implementation of new projects, collaborating with the team leader/activity manager/project manager.
  • Serve as the primary contact for projects under the guidance of the team leader/activity manager/project manager, providing excellent client communication skills and project management expertise.
  • Conduct medical reviews of post-marketing cases as assigned, leveraging strong pharmaceutical background and knowledge of regulatory requirements.
  • Lead operations for assigned post-marketing clients, overseeing case review and analysis processes, and developing strategic plans to meet client needs.
Requirements
  • Pharmacist or Life Sciences degree with more than 3 years of experience in Pharmacovigilance (PV).
  • Proven ability to work under deadlines, meeting project milestones and delivering high-quality results.
  • Excellent client communication skills, with ability to build strong relationships with clients and partners.
  • Strong pharmaceutical background with an understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • In-depth knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
  • Minimum 3 years of experience working for service providers performing QC of cases.
What We Offer
  • A dynamic and collaborative work environment, with opportunities for growth and professional development.
  • Competitive compensation and benefits package, recognizing your value and contributions to our team.
  • The chance to work on challenging projects, applying your expertise and skills to drive meaningful outcomes.
  • A supportive and inclusive culture, valuing diversity and promoting a healthy work-life balance.

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