BioSpace
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Group Medical Director, Patient Safety
role at
BioSpace
Company Description AbbVie 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, eye care and products and services in our Allergan Aesthetics portfolio.
Purpose Group Medical Director manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and PST leads (and could support one large product as the PST Lead) and ensuring safety of late stage and post marketing hematology-oncology portfolio (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
Responsibilities
Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc)
Asset strategy lead safety representatives for larger programs (late stage)
Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery
Works closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA
Leads and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA
Proactively seeks to understand WHY a safety concern or risk emerge and How to mitigate it
Understanding and application of the pharmacology and chemistry 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 (PSURs, PADERs 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.
Qualifications
MD / DO with 2+ years of residency with patient management experience
Master Public Health or PhD is preferred in addition to MD / DO, not required
8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
Effectively analyze and guide analysis of clinical data and epidemiological information
Effectively present recommendations / opinions in group environment both internally and externally
Write, review and provide input on technical documents
Work collaboratively and lead cross-functional teams
Ability to lead cross-functional teams in a collaborative environment
Fluency, both written and oral, in English
Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask
Additional Information Compensation range: $195,000-$254,000. Benefits include paid time off, medical/dental/vision insurance and 401(k). The role is eligible for short-term and long-term incentive programs. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Group Medical Director, Patient Safety
role at
BioSpace
Company Description AbbVie 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, eye care and products and services in our Allergan Aesthetics portfolio.
Purpose Group Medical Director manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and PST leads (and could support one large product as the PST Lead) and ensuring safety of late stage and post marketing hematology-oncology portfolio (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
Responsibilities
Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc)
Asset strategy lead safety representatives for larger programs (late stage)
Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery
Works closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA
Leads and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA
Proactively seeks to understand WHY a safety concern or risk emerge and How to mitigate it
Understanding and application of the pharmacology and chemistry 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 (PSURs, PADERs 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.
Qualifications
MD / DO with 2+ years of residency with patient management experience
Master Public Health or PhD is preferred in addition to MD / DO, not required
8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
Effectively analyze and guide analysis of clinical data and epidemiological information
Effectively present recommendations / opinions in group environment both internally and externally
Write, review and provide input on technical documents
Work collaboratively and lead cross-functional teams
Ability to lead cross-functional teams in a collaborative environment
Fluency, both written and oral, in English
Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask
Additional Information Compensation range: $195,000-$254,000. Benefits include paid time off, medical/dental/vision insurance and 401(k). The role is eligible for short-term and long-term incentive programs. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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