AbbVie
Overview
Base pay range: $177,000.00/yr - $336,000.00/yr. This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
AbbVie is a pharmaceutical company focused on discovering and delivering innovative medicines and solutions. The company aims to have a remarkable impact on people’s lives in therapeutic areas including immunology, oncology, neuroscience, and eye care, with products and services in the Allergan Aesthetics portfolio.
Job Description Purpose:
To lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle (e.g., surveillance, signal detection and evaluation, risk management, etc.). Interpret regulations related to pharmacovigilance supporting all patient safety activities.
Location:
Open for all AbbVie office locations in the US.
Responsibilities
Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
Responsible for safety surveillance for pharmaceutical / biological / drug–device combination products.
Lead, oversee, and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses, risk management plans, and periodic safety reports (DSURs, PBRERs/PSURs, PADERs).
Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance as appropriate.
Analyze and interpret aggregate safety data and communicate analyses to cross-functional teams and regulatory authorities.
Independently write, review, and present technical documents.
Implement risk management strategies for assigned products.
Engage, inspire, coach and mentor team and colleagues.
Qualifications
MD / DO with 2+ years of residency with patient management experience.
Master of Public Health is preferred in addition to MD / DO, not required.
2-5 years of pharmacovigilance / clinical development experience in the pharmaceutical industry.
Ability to analyze and guide analysis of clinical data and epidemiological information.
Ability to present recommendations in group settings both internally and externally.
Experience writing, reviewing and providing input on technical documents.
Ability to work collaboratively and lead cross-functional teams.
Fluency in English (written and spoken).
Ability to make independent decisions and multitask in situations of uncertainty and complexity.
Additional Information
The compensation range described is the range of possible base pay compensation the Company believes in good faith it will pay for this role at the time of posting. Individual compensation will depend on factors including geographic location and may be higher or lower than the posted range.
The company offers a comprehensive benefits package including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in short-term and long-term incentive programs.
Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. Benefits are at the Company’s discretion and may be modified in accordance 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 AbbVie Equal Employment Opportunity Employer page. If you require a reasonable accommodation, click the related link to learn more.
#J-18808-Ljbffr
AbbVie is a pharmaceutical company focused on discovering and delivering innovative medicines and solutions. The company aims to have a remarkable impact on people’s lives in therapeutic areas including immunology, oncology, neuroscience, and eye care, with products and services in the Allergan Aesthetics portfolio.
Job Description Purpose:
To lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle (e.g., surveillance, signal detection and evaluation, risk management, etc.). Interpret regulations related to pharmacovigilance supporting all patient safety activities.
Location:
Open for all AbbVie office locations in the US.
Responsibilities
Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
Responsible for safety surveillance for pharmaceutical / biological / drug–device combination products.
Lead, oversee, and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses, risk management plans, and periodic safety reports (DSURs, PBRERs/PSURs, PADERs).
Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance as appropriate.
Analyze and interpret aggregate safety data and communicate analyses to cross-functional teams and regulatory authorities.
Independently write, review, and present technical documents.
Implement risk management strategies for assigned products.
Engage, inspire, coach and mentor team and colleagues.
Qualifications
MD / DO with 2+ years of residency with patient management experience.
Master of Public Health is preferred in addition to MD / DO, not required.
2-5 years of pharmacovigilance / clinical development experience in the pharmaceutical industry.
Ability to analyze and guide analysis of clinical data and epidemiological information.
Ability to present recommendations in group settings both internally and externally.
Experience writing, reviewing and providing input on technical documents.
Ability to work collaboratively and lead cross-functional teams.
Fluency in English (written and spoken).
Ability to make independent decisions and multitask in situations of uncertainty and complexity.
Additional Information
The compensation range described is the range of possible base pay compensation the Company believes in good faith it will pay for this role at the time of posting. Individual compensation will depend on factors including geographic location and may be higher or lower than the posted range.
The company offers a comprehensive benefits package including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in short-term and long-term incentive programs.
Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. Benefits are at the Company’s discretion and may be modified in accordance 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 AbbVie Equal Employment Opportunity Employer page. If you require a reasonable accommodation, click the related link to learn more.
#J-18808-Ljbffr