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Pharmacovigilance Leader
Ref No.: 16-00256
Location: East Hanover, New Jersey
Position Type:Full Time/Contract
Start Date / End Date: 11/02/2015 to 05/02/2016
Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator notifications.
Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection monitoring and evaluation based on single cases, aggregate data and signal detection tools, i.e. EMPIRICA
Prepares clinical expert statements and provides input in responses to inquiries from regulatory authorities or healthcare professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues
Provides Pharmacovigilance input to initial development of basic prescribing information and is responsible for Pharmacovigilance input into updates of this information
Prepares medical input to aggregate clinical safety regulatory reports
Provide input to safety profiling and risk management plan
Provide guidance as appropriate to Clinical Safety Operations for the coding and causality/expectedness assessment of adverse event reports
Provide expert evaluation on the clinical context of adverse event report, assessment on the medical conditions and the implications on Client drugs
Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments
Provides relevant input for internal and external boars and expert panels as well as internal management teams as SPT, SMT, GPT as needed.
Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
Skills:3 years Specific Pharma Industry experience required