Post-marketing product surveillance to include but not limited to proactive product monitoring, adverse event trending, signal detection and signal management. Provide risk assessments when applicable. Represent Pharmacovigilance in cross-functional product surveillance teams.
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The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing and/or reviewing signal detection reports, aggregate reports (DSURS, PSURS, PBRERs. PADERS), and risk management reports (RMPs). The Senior PV Physician I is also expected to support the QPPV in medical aspects and safety issues as may be required by Company or Client.