Director/Senior Medical Director

Summary

Join AbbVie as an Indication Product Safety Lead and contribute to the lifecycle management of pharmaceutical/biological/drug-device products. You will be responsible for safety surveillance, data interpretation, and regulatory compliance. Key responsibilities include leading the strategy and authoring key safety documents, analyzing aggregate safety data, and collaborating with cross-functional teams. The role requires strong communication and leadership skills, along with experience in pharmacovigilance and clinical development. AbbVie offers a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and 401(k). Opportunities for short-term and long-term incentives are also available.

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 or other relevant experience
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Strong communicator, who is able to effectively present recommendations / opinions in group environment both internally and externally
• Write, review and provide input on technical documents
• Able work collaboratively and lead cross-functional team
• Formulates independent decisions

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 combined products
• Leading, setting the strategy and, when appropriate, authoring the key documents with safety data, including but not limited to, medical safety assessments, parts of submission dossier and regulatory responses
• Applying current regulatory guidance as appropriate for safety surveillance
• Analyzing, interpreting, and summarizing aggregate safety data and communicating these analysis and interpretation to cross-functional teams and senior management
• Independently writing, reviewing, and providing input on technical documents
• Providing oversight, leading the strategy as well as authoring when applicable, the key sections for periodic reports (e.g. PSURs, DSURs, PADERs and Safety sections of the IBs)
• Leading and setting the strategy, in collaboration with the development medical lead of study protocols and informed consents
• Defining and implementing risk management strategies for assigned product/indication
• Proactively engaging, inspiring, coaching and mentoring team members and colleagues
• Co-authoring publications and developing and growing as a safety leader

Preferred Qualifications

Master Public Health

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs