Group Medical Director, Product Safety Teams

3 weeks ago


North Chicago Illinois, United States AbbVie Full time
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 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 analysis and interpretation to cross-functional teams

Effectively write, review and provide input on technical documents independently Oversight and responsibility for leading 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

Proactively engaging, inspiring, coaching and mentoring team and colleagues

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 hr day) is required

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required



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