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Reporting to: Pharmacovigilance Manager
Desirable qualifications and background
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Bachelor or Master's degree in life sciences, pharmacy, nursing or RN
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At least 3 years of pharmacovigilance experience in the pharmaceutical/CRO industry
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Strong knowledge of ICH guidelines and other applicable regulatory requirements.
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Good ability to express yourself both verbally and in writing
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Good knowledge of spoken and written English
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Good organizational skills
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Experience of mentoring junior Pharmacovigilance personnel
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Ability to prioritize and handle several tasks simultaneously
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Strong interpersonal skills and the ability to build relationships both internally and externally
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Demonstrate willingness to take on any level project activity consistent with current or past experience.
Principal duties
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Collect and review Adverse Drug Reactions(ADR) / Adverse events
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Write detailed description of the pharmacovigilance system
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Database entry of ADR and SAE in the internal safety database
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MedDRA coding
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Seriousness, expectedness and causality assessment
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QC of database entry
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Report safety information to Regulatory Authorities.
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Worldwide literature search
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Draft Periodic Safety Update Reports (PSUR) and Annual Safety Reports
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Support Clients in the EudraVigilance registration process
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Eudravigilance testing
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Register products in the EudraVigilance Medicinal Product Dictionary
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Archiving of Pharmacovigilance documents
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Provide training for colleagues on pharmacovigilance, administrative, and company procedures and processes.
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