Allergan
Associate Medical Director/Medical Director, Medical Safety Evaluation, Translat
Allergan, Dallas, Texas, United States, 75215
Company Description
AbbVie'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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us. Follow on social channels.
Job Description Purpose:
Supporting the Product Safety Leads (PSTLs) and potentially leading one or more products as the PSTL under the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, and assessment. Interpreting regulations related to pharmacovigilance, supporting all patient safety activities.
Responsibilities
Understands and applies pharmacology, chemistry, and non-clinical toxicology to effectively conduct safety surveillance
Conducts safety surveillance for pharmaceutical/biological/drug–device combined products; contributes to the authorship of key pharmacovigilance documents, including but not limited to medical safety assessments, regulatory responses, and risk management plans
Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyzes and interprets aggregate safety data and communicates these analyses and interpretations to cross-functional teams
Effectively writes, reviews, and provides input on technical documents
Leads the strategy for periodic reports (DSURs, PSURs, PADERs, etc.)
Oversees safety surveillance and pharmacovigilance activities for products in clinical trials
Leads and implements risk management strategy for assigned products
Key Stakeholders:
Group Medical Director, Executive Director, TA Head, PST Lead, Analytics/Data Scientists, Project Management and Data Management, Clinical Development, Preclinical Safety, Precision Medicine
Qualifications
MD/DO with 2+ years of residency with patient management experience
2–4 years of pharmacovigilance experience in the pharmaceutical industry
Effectively analyzes and guides analysis of clinical data and epidemiological information required
Effectively writes technical documents with direction
Ability to effectively present recommendations/opinions in a group environment
Fluency, both written and oral, in English
Self-starting and can work independently
Works collaboratively and leads cross-functional teams
Additional Information
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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.
US & Puerto Rico only - to learn more, visit the removed-links version of the equality page.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Removed links for accommodation information.
#J-18808-Ljbffr
Job Description Purpose:
Supporting the Product Safety Leads (PSTLs) and potentially leading one or more products as the PSTL under the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, and assessment. Interpreting regulations related to pharmacovigilance, supporting all patient safety activities.
Responsibilities
Understands and applies pharmacology, chemistry, and non-clinical toxicology to effectively conduct safety surveillance
Conducts safety surveillance for pharmaceutical/biological/drug–device combined products; contributes to the authorship of key pharmacovigilance documents, including but not limited to medical safety assessments, regulatory responses, and risk management plans
Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyzes and interprets aggregate safety data and communicates these analyses and interpretations to cross-functional teams
Effectively writes, reviews, and provides input on technical documents
Leads the strategy for periodic reports (DSURs, PSURs, PADERs, etc.)
Oversees safety surveillance and pharmacovigilance activities for products in clinical trials
Leads and implements risk management strategy for assigned products
Key Stakeholders:
Group Medical Director, Executive Director, TA Head, PST Lead, Analytics/Data Scientists, Project Management and Data Management, Clinical Development, Preclinical Safety, Precision Medicine
Qualifications
MD/DO with 2+ years of residency with patient management experience
2–4 years of pharmacovigilance experience in the pharmaceutical industry
Effectively analyzes and guides analysis of clinical data and epidemiological information required
Effectively writes technical documents with direction
Ability to effectively present recommendations/opinions in a group environment
Fluency, both written and oral, in English
Self-starting and can work independently
Works collaboratively and leads cross-functional teams
Additional Information
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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.
US & Puerto Rico only - to learn more, visit the removed-links version of the equality page.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Removed links for accommodation information.
#J-18808-Ljbffr