Group Medical Director, Pharmacovigilance
Found in: Resume Library US A2 - 1 week ago
Purpose:
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and supports one or more psychiatry products as the PST Lead. Ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
Responsibilities:
Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret aggregate safety data and communicate these analyses and interpretations to cross-functional teams
Effectively write, review and provide input on technical documents independently. Contribute to the strategy for periodic reports (PSUR’s, PADER’s etc.)
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing.
Responsible for implementing risk management strategies for assigned products
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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Group Medical Director, Product Safety Teams
10 hours ago
North Chicago, United States AbbVie Full time**Company Description** **Job Description** Purpose**: Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and...
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Sr Medical Director
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Found in: Resume Library US A2 - 1 week ago
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Found in: Resume Library US A2 - 1 week ago
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Found in: Resume Library US A2 - 1 week ago
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Found in: beBee S US - 1 week ago
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Found in: Resume Library US A2 - 1 week ago
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Group Art Supervisor
Found in: Resume Library US A2 - 1 week ago
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Reporting Specialist
Found in: beBee jobs US - 1 week ago
Chicago, Illinois, United States Orion Group Full time$27 - $30 per hour with option for medical benefits6 month initial contractHybrid schedule after training - standard first shift business hoursLocation: North Chicago, ILOrion Group and our client a market leading pharmaceutical company, have an exciting contract opportunity for a Reporting Specialist in North ChicagoWe are seeking candidates with Knowledge...
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Found in: Resume Library US A2 - 5 days ago
North Chicago, Illinois, United States AbbVie Full timeJob Description The Pipeline Commercialization & Strategy (PCS) organization leads the development of the commercial strategy for key assets in AbbVie’s pipeline. The role of the Sr Manager / Associate Director, Pipeline Commercialization & Strategy (PCS) is to partner with the Director, CNS, Eyecare and Specialty Pipeline Forecasting in the planning,...
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Found in: Resume Library US A2 - 1 week ago
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Found in: Careerbuilder One Red US C2 - 8 hours ago
North Chicago, IL 60086, USA, United States AbbVie, Inc Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in...
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Found in: Resume Library US A2 - 1 week ago
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