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Drug Safety:
Clinical Safety, Case Management, Global/ Local Literature Search, Medical Reviews, Aggregate Safety Report Authoring, EU & UK QPPV, Signal Evaluation & Risk Management, Submissions, PV Operation Services, PV Quality, Audits, Inspection Readiness & Compliance Management, Safety Data Exchange Agreements (SDEA’s) & Pharmacovigilance Agreements (PVAs) Authoring.
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Pharmacovigilance
- Safety data collection, evaluation & reporting
- Signal detection & risk management plans
- Aggregate safety reports (PBRERs, PSURs, DSURs)
- Pharmacovigilance system setup & audits
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