Company DescriptionJob Description
Purpose :
The Product Safety Team (PST) lead for early oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the early oncology programs.
The PST lead will also closely collaborate with a PK and toxicology leads to help guide dose selection and regimen, inclusion / exclusion criteria and safety monitoring for first in human and phase I / II studies.
The PST lead will be responsible and provide safety oversight (e.g. surveillance, signal detection, validation, and assessment) for early oncology products with a proactive approach to clinical safety, and will be interpreting regulations related to pharmacovigilance to support 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 early oncology products
- Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports.
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents
- Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
- Independently write, review, and provide input on technical documents
- Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.
g. DSUR’s, PADER’s and Safety sections of the IBs)
- Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents
- Responsible for implementing risk management strategies for assigned product
- Proactively engaging, inspiring, coaching and mentoring team members and colleagues
- Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
- Strong team player, able to adapt and work in a fast pace environment
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
Qualifications :
- MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD is preferred in addition to MD / DO, not required
- 5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
- Oncology experience and early development experience strongly preferred
- 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
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 committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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