Safety Deliverable Manager
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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose: This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) organization’s Global PV Strategy Management Office. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.
The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the product lifecycle. The team partners with stakeholders across the product lifecycle to provide innovative safety-driven strategies, which will maximize product benefit-risk for patients.
As a Safety Deliverable Manager within the Office of the PST, you are in a highly visible role that provides various opportunities to influence and drive operational excellence by providing strategic management and quality authoring of PST Safety Deliverables.
Responsibilities:
Demonstrates advanced project management skills to lead strategy discussions and drive completion of mature and non-mature product safety deliverables (e.g., aggregate safety reports, assessment reports, medical safety assessments) with increasing autonomy and in accordance with regulatory requirements and procedures, and in collaboration with cross-functional stakeholders.
With increasing autonomy, applies sound medical judgment to effectively evaluate, interpret, and synthesize scientific data and translate into clear and concise safety summaries for inclusion in mature product safety deliverables.
With oversight, applies solid knowledge and understanding of applicable regulations (e.g., ICH, FDA, EMA, GCP) to lead authoring and review of assigned safety deliverables in accordance with standard operation procedures.
Identifies and manages emerging risks and issues that arise during preparation of safety deliverables (e.g., risk to timeline, new regulatory request impacting the deliverable) and ensures they are mitigated and escalated as appropriate.
Drives document quality through execution of quality control measures (i.e., safety deliverable QC, oversight of stakeholder review, and archival of supporting documents).
Leverages applicable systems, regulations and processes to enable successful, on-time completion of safety deliverables.
Mentors, and supports training of, less experienced Safety Deliverable Excellence team members on targeted SDE processes as directed.
Works and collaborates effectively to build, leverage and maintain relationships across functions and organizations to create high quality safety deliverables within specified timeframes.
Proactively seeks out opportunities to improve overall safety deliverable operational and quality
This role can be located with the United States or Romania. Title and grading will be to adapted to the host country. Compensation will be to your country of residence.
There is the potential for this role to be a Senior Manager level role, depending on experience.
Qualifications
Required education:
Bachelor’s degree in a Health Sciences discipline (e.g., Pharmacy, Nursing, or other healthcare profession)
Preferred education
Master’s or advanced degree is desirable
Required Experience
At least 3 years of pharmaceutical industry experience for Manager level; Experience within Pharmacovigilance, medical writing, and/or post-marketing aggregate report authoring is desirable but not required.
At least 5 years of pharmaceutical industry experience, with more than 3 years of aggregate safety report authoring experience for Senior Manager level.
Excellent written and spoken English
Demonstrated working knowledge of global regulatory framework for aggregate safety reports
Solid understanding of medical concepts and familiarity with drug development and postmarketing safety activities
Understanding of tools, standards and approaches used to evaluate drug safety
Exposure to medical and scientific writing, with ability to analyze, interpret and synthesize medical scientific data and translate it into a succinct and concise written summary
Familiarity with working in a multidisciplinary, matrix team situation while also independently carrying out responsibilities
Extremely detail oriented with excellent project management skills and proficiency with Microsoft Office applications (e.g., Word, Excel, PowerPoint)
Effectively manage stressful situations, multiple projects simultaneously and tight project milestone
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
About the job
Apply for this position
Safety Deliverable Manager
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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose: This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) organization’s Global PV Strategy Management Office. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.
The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the product lifecycle. The team partners with stakeholders across the product lifecycle to provide innovative safety-driven strategies, which will maximize product benefit-risk for patients.
As a Safety Deliverable Manager within the Office of the PST, you are in a highly visible role that provides various opportunities to influence and drive operational excellence by providing strategic management and quality authoring of PST Safety Deliverables.
Responsibilities:
Demonstrates advanced project management skills to lead strategy discussions and drive completion of mature and non-mature product safety deliverables (e.g., aggregate safety reports, assessment reports, medical safety assessments) with increasing autonomy and in accordance with regulatory requirements and procedures, and in collaboration with cross-functional stakeholders.
With increasing autonomy, applies sound medical judgment to effectively evaluate, interpret, and synthesize scientific data and translate into clear and concise safety summaries for inclusion in mature product safety deliverables.
With oversight, applies solid knowledge and understanding of applicable regulations (e.g., ICH, FDA, EMA, GCP) to lead authoring and review of assigned safety deliverables in accordance with standard operation procedures.
Identifies and manages emerging risks and issues that arise during preparation of safety deliverables (e.g., risk to timeline, new regulatory request impacting the deliverable) and ensures they are mitigated and escalated as appropriate.
Drives document quality through execution of quality control measures (i.e., safety deliverable QC, oversight of stakeholder review, and archival of supporting documents).
Leverages applicable systems, regulations and processes to enable successful, on-time completion of safety deliverables.
Mentors, and supports training of, less experienced Safety Deliverable Excellence team members on targeted SDE processes as directed.
Works and collaborates effectively to build, leverage and maintain relationships across functions and organizations to create high quality safety deliverables within specified timeframes.
Proactively seeks out opportunities to improve overall safety deliverable operational and quality
This role can be located with the United States or Romania. Title and grading will be to adapted to the host country. Compensation will be to your country of residence.
There is the potential for this role to be a Senior Manager level role, depending on experience.
Qualifications
Required education:
Bachelor’s degree in a Health Sciences discipline (e.g., Pharmacy, Nursing, or other healthcare profession)
Preferred education
Master’s or advanced degree is desirable
Required Experience
At least 3 years of pharmaceutical industry experience for Manager level; Experience within Pharmacovigilance, medical writing, and/or post-marketing aggregate report authoring is desirable but not required.
At least 5 years of pharmaceutical industry experience, with more than 3 years of aggregate safety report authoring experience for Senior Manager level.
Excellent written and spoken English
Demonstrated working knowledge of global regulatory framework for aggregate safety reports
Solid understanding of medical concepts and familiarity with drug development and postmarketing safety activities
Understanding of tools, standards and approaches used to evaluate drug safety
Exposure to medical and scientific writing, with ability to analyze, interpret and synthesize medical scientific data and translate it into a succinct and concise written summary
Familiarity with working in a multidisciplinary, matrix team situation while also independently carrying out responsibilities
Extremely detail oriented with excellent project management skills and proficiency with Microsoft Office applications (e.g., Word, Excel, PowerPoint)
Effectively manage stressful situations, multiple projects simultaneously and tight project milestone
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html