Job Description

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Essential Functions
• Reviews all applicable ICSRs, and communicates with Global Case Management Team, Medical Safety Management team within Medical Safety, and others, such as CROs, or vendors, when necessary
• Perform medical review all types of Individual case safety reports (ICSR) from all sources such as health authority reports, clinical trials, post marketing spontaneous, literature, solicited reports
• Perform causality assessment for all events based on WHO algorithm and ICH guidelines also taking into consideration company conventions and creates company clinical evaluation comment
• Perform seriousness assessment and labeling assessment for adverse events with reference to different types of product safety information such as USPI, Canadian Product Monograph, SmPC, CCDS, IB
• Medical review of MedDRA coding of adverse events, indications, laboratory data, medical history or surgical procedures and narratives
• Raise follow up queries for additional information needed for medical assessment
• Review, identify potential signals from ICSRs and escalates issues / concerns to team lead in a timely and appropriate manner
Required Knowledge, Skills, and Abilities
Minimum Requirements
• At least 3-4 years of experience in PV, as ICSR Medical Reviewer, primary clinical cases, oncology experience
• Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice
• PV regulations knowledge including but not limited to ICSRs processing, aggregate safety reports, risk management plans, and signal management in different jurisdictions.
• In-depth knowledge of medical and drug terminology, as well as the clinical development process.
• Knowledge with MedDRA coding and Argus safety databases.
• Proficiency with Windows applications, and ability to learn new programs / databases.
• Ability to critically evaluate safety data from multiple sources (clinical trials, literature, etc.), assesses clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communication is required.

Required/Preferred Education and Licenses
• Requires a MD degree and a license in one country

Job Tags

Remote job, Contract work,

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