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Post : Pharmacovigilance Services Specialist - Life Sciences R&D
Job Description :
• Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labeling, causality and provide a medical assessment comment as needed for ICSR.
• Reviews medical content and quality of the Case and ensures that all events from the source documents are accurately coded and verify consistency between source documents and narrative summary.
• Ensures all relevant information is in logical temporal sequence
• Actively follow up of adverse events to obtain more information and review of all letters and queries for appropriateness and completeness. Start an Ad-hoc follow-up whenever required.
• Constantly update domain and operations skills as per the changing Regulatory requirements by reading the updated version of SOP.
• Route the Case to Distribution and ensure the case is locked.
• Provide feedback for the Case creation and data entry production leads about the quality of data entry in serious cases.
• Actively involved in case discussion with client and provide the valuable inputs to the team.
• Offline peer review of agreed sample of Cases for assessment of quality of narrative, E2B sender’s comment and medical query completeness
• To participate in audits or inspections.
• Open to get trained and moved across roles based on business requirement.
• Training and mentoring of new associates.
• Authoring of process documents.
Bachelor of Pharmacy
Experience : 7 - 10 Years
Qualification : Bachelor of Pharmacy
Location : Bengaluru
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Pharmacovigilance - Medical Review
End Date : 30th September, 2023
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