Medical Reviewer

ProductLife Group is looking for Medical Reviewers having minimum 5 years of experience in Pharmacovigilance Medical Reviewing.

Responsibilities:

Clinical Phase:

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• Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).
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• Make assessments on SUSAR reportability.
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• Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required).
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• Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.
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Post-Marketing (Pharmacovigilance)

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• Support in maintenance of medical platform including SOPs, manual and documents.
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• Interaction with the clients medical team and clinical team
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• Medical review of the ICSRs (e.g., Spontaneous, literature)
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• Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
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• Provide feedback and ongoing workshops to develop the medical reviewers.
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• Participate in audits and inspections as required
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• Ensure understanding of client needs, conventions and ensure expectations are met and exceeded
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Required Education:

MBBS, or MD (Doctor of Medicine)

Required Experience:

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• Client communications
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• Safety Database experience
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• Minimum 5 years experience working for service providers or pharmaceutical company.
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Required technical skills:

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• Microsoft package
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• Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
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• Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
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• Working knowledge of EDC systems
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• Good Medical knowledge and Pharmacology understanding
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Additional experience and/or skills:

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• Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
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• Experience with DSMB preferred.
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• Ability to deliver constructive feedback
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• Emotional intelligence
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• Adaptability
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• Analytical skills
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• Flexibility
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• Reliable
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• Strong organisation skills
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• Punctual
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• Database experience
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