Senior Medical Director, Product Safety Lead (Remote)
- Full-time
- Salary Min: 195000
- Salary Max: 371000
- Area of Interest: Pharmacovigilance
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.
Serve as Indication Product Safety Lead for one or more products or product indications under the direction of the Therapeutic Area (TA) Lead and Global TA. Ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting 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 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. PSURs, DSURs, PADERs and Safety sections of the IBs)
- Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents
- 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
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.
Minimum Requirements:
- MD / DO with 2+ years of residency with patient management experience; Master Public Health is preferred in addition to MD / DO, not required
- 5 - 8 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 team in a collaborative environment
- Evaluate and make independent decisions
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
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