Job Description
Case Specialist (ProductLife Group - Philippines, Remote Possible)
Location: Philippines
Category: Safety and Vigilance
Contract Type: Permanent
About ProductLife Group:
ProductLife Group is seeking a dedicated Case Specialist to join our dynamic team and contribute to the ongoing activities performed within the Hub.
Key Responsibilities:
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Vigilance Case Management:
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Data entry of vigilance cases into relevant databases following applicable conventions.
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Quality control (QC) of vigilance cases and safety-related documents.
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Medical review of vigilance cases according to conventions and regulatory requirements.
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Follow-up on vigilance cases through phone or email.
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Pre-analysis of complex cases before data entry.
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Identification of submission requirements for safety cases.
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Analysis and Review:
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Identify requirements for ICSR/MLM filter preparation.
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Review and analyze ICSRs downloaded from competent authority databases.
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Perform reconciliations (partners, medical information, quality complaints).
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Participate in the operational implementation of new projects.
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Act as key contact for projects with the support of the team leader, activity manager, or project manager.
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Medical Review and Operations Lead:
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Perform medical review of post-marketing cases as assigned.
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Serve as the Operations Lead for assigned post-marketing clients.
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Documentation and Compliance:
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Draft and update technical agreements, safety management plans, and client templates.
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Draft and update SOPs, WPDs, training materials, and other related documents.
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Participate in process implementation, maintenance, and continuous improvement.
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Education and Experience:
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Pharmacist or Life Sciences degree with over 3 years of experience in pharmacovigilance.
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Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
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Minimum 3 years of experience working for service providers performing QC of cases.
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Experience using SafetyEasy database.
Required Skills/Competencies:
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Proven ability to meet deadlines and manage multiple projects.
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Strong communication skills with clients.
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Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
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Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
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